As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Sayar Food Market Inc.Revere, MA
An import company in Massachusetts is on notice from the FDA for not having FSVPs for a number of imported food products.
In a July 13 warning letter, the FDA described a Feb. 16 through March 8 remote Foreign Supplier Verification Program (FSVP) inspection of Sayar Food Market Inc. in Revere, MA.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop, maintain, and follow an FSVP for any of the foods they import including each of the following food products:
(Redacted) imported from (redacted)
(Redacted) imported from (redacted)
(Redacted) imported from (redacted)
In addition to the above violations, the FDA also had the following comments:
The firm’s store manager reported that they do not directly import food products from multiple individual foreign firms, but instead from (redacted), located in (redacted). The store manager also stated her understanding that the firm did not need to comply with the FSVP regulation because the products were imported from (redacted), a country FDA has recognized as having an equivalent food safety system to that of the United States.
The FSVP regulation defines a foreign supplier, in part, as the establishment that manufactures/processes the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.
(Redacted), located in (redacted), does not appear to meet the definition of a foreign supplier. Furthermore, if they did import certain food from a foreign supplier in, and under the regulatory oversight of, a country with an officially recognized or equivalent food safety system, they would still need to have an FSVP for those foods, but they could choose to follow the modified requirements applicable to such food in 21 CFR 1.513, including that before importing the food, they must determine and document whether the foreign supplier of the food is in good compliance standing with the food safety authority of the country in which the foreign supplier is located, as required.
The full warning letter can be viewed here.
Acme Smoked Fish Corp.Brooklyn, NY
An import company in Brooklyn is on notice from the FDA after an inspection found the presence of Salmonella in their RTE cold smoked tuna product and FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes in their facility.
In a July 12 warning letter, the FDA described a Jan. 6, 7, 11, 13, 19-21, 25, 26, 29 and Feb. 10, 2021, inspection of Acme Smoked Fish Corp.’s ready-to-eat (RTE) hot and cold smoked seafood processing facility in Brooklyn, NY.
The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. The significant violations are as follows:
Presence of pathogens in seafood
SalmonellaSalmonella species are not endemic to seafood; therefore, the FDA expects zero or non-detectable levels of Salmonella in seafood regardless of whether it is intended to be cooked before consumption or it is ready-to-eat (RTE). Salmonella in seafood results from human or animal fecal contamination of the harvest waters and/or fecal contamination during post-harvest handling and processing. The contamination can also be exacerbated by temperature abuse. Cold smoking does not achieve temperatures that are considered a pathogen kill step, and cold smoked tuna is considered a raw RTE product that must have appropriate controls from harvest to consumption. Many strains of Salmonella have a very low infective dose, making prevention critical.
On Jan. 11 FDA collected from the firm’s facility eleven (11) finished product samples of their RTE cold smoked tuna which were on hold due to their own finished product testing detecting Salmonella. FDA analysis found Salmonella in two of the 11 samples of the finished product, Sample 1153334 packaged on July 18, 2020, and Sample 1153332 packaged on July 23, 2020. These products were not distributed and were on hold at their facility pending destruction. These results and our serious food safety concerns related to these findings were discussed with them during a conference call on Jan. 22, 2021.
Prior to the issuance of this Warning Letter, the FDA updated the Whole Genome Sequencing (WGS) analysis. WGS was conducted on six Salmonella isolates obtained from the FDA Sample 1153332 of cold smoked tuna finished product collected on Jan. 11; and six Salmonella isolates obtained from the FDA Sample 1153334 of cold smoked tuna finished product collected on Jan. 11. The current WGS analysis determined that the isolates derived from their finished product samples are comprised of two different strains of Salmonella. Specifically of significance, one of these strains included six isolates from Sample 1153332 and four isolates from Sample 1153334 that were determined to be a genomic match to an import product sample of raw tuna collected by FDA from their foreign tuna supplier on Feb. 10; and two clinical isolates collected in 2020 and 2021, which confirms that this strain has the capability of causing human illness. There is currently no food history or traceback information available for the 2020 and 2021 clinical isolates. Tfe FDA advised the firm of the initial WGS results via a conference call on March 18.
The firm’s response includes descriptions of the corrective actions that they have taken, including updating their approved supplier program for tuna used for cold smoking. The FDA response states that they now require testing records, testing method, and lab credentials for raw tuna suppliers. Their response also states that they will also perform raw material pathogen testing for ingredients, including tuna and sesame seeds. Additionally, their March 8 response includes a copy of their approved supplier program, effective date of Feb. 24, which was updated to include raw material testing by their firm using a third-party laboratory for ingredients used in their cold smoked products and corrective actions for noncompliant results. Further, their March 19 response indicates that they will no longer purchase raw tuna from a specific supplier and processor, and that they are searching for new suppliers.
The firm’s corrective actions include raw material testing. Note that raw material testing alone is unlikely to be sufficient, since Salmonella contamination is not homogeneously distributed in food; microbiological testing is generally used to verify the adequacy of other control measures. Because seafood contaminated with Salmonella is the result of insanitation, FDA recommends that if they use their previous supplier they obtain evidence that the manufacturer of their raw materials has made significant improvements in sanitation procedures and sanitation control measures to prevent adulteration by Salmonella.
Additionally, the FDA recommends their supplier program for raw tuna intended to be cold smoked include obtaining the manufacturer’s sanitation procedures and controls. The firm should also ensure that the manufacturer’s HACCP plan acknowledges that raw tuna is a RTE food and the HACCP plan has adequate controls to prevent pathogen growth and toxin formation. The firm’s response to this warning letter should include a copy of their revised supplier approval program, raw material testing for tuna and sesame seeds to demonstrate implementation of their above stated corrective actions, and the HACCP plan and sanitation procedures for the manufacturer of their current source of raw tuna. Additional deficiencies with their corrective actions regarding Salmonella found in their cold smoked tuna through the firm’s own finished product testing are discussed later in this letter.
Listeria monocytogenesListeria monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to apply controls or take corrective actions as necessary to eradicate the organism.
FDA laboratory analysis of the environmental sample 1083726 collected on Jan. 6 during the production of the firm’s RTE cold smoked tuna, confirmed 1 out of 100 environmental swabs collected was positive for Listeria monocytogenes. The positive swab was collected from the floor area adjacent to their cooler #6 used to store RTE seafood salads and their ingredients and immediately adjacent to the hallway’s foot bath. Appropriate control of Listeria monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and the corresponding hygienic practices necessary to control this pathogen.
Prior to the issuance of this Warning Letter, the Agency updated the Whole Genome Sequencing (WGS) analysis. WGS was conducted on seven Listeria monocytogenes isolates obtained from the FDA environmental sample 1083726 collected on January 6, 2021. The current WGS analysis determined that these isolates were a genomic match to each other, representing a single strain of Listeria monocytogenes. At this time, no additional isolates were determined to match this strain of Listeria. monocytogenes. Additionally, WGS analysis was conducted on Listeria monocytogenes isolates obtained from two product samples of cold smoked nova salmon collected by FDA from their facility in 2007. The current WGS analysis determined that these isolates were a genomic match to four clinical isolates collected in 2007, 2019, and 2020, which confirms that this strain has the capability of causing human illness. There is currently no food history or traceback information available for the 2007, 2019, and 2020 clinical isolates. The FDA advised the firm of the initial WGS results via a conference call on Feb. 3.
Additionally, on Nov. 16, 2020, the firm was notified by a customer that their hot smoked ground trout, used as an ingredient in their customer’s finished product, tested positive for Listeria monocytogenes. The firm provided the customer with documentation that environmental monitoring is performed daily, and finished product testing is performed annually for pathogens across all product categories and no issues or trends were identified.
However, Listeria monocytogenes is not homogeneously distributed, and it is not uncommon for product to test negative even when contamination has occurred, particularly when the number of organisms is low. This fact underscores the importance of environmental monitoring and taking adequate corrective actions. The goal of environmental sampling is to verify the effectiveness of their control programs for L. monocytogenes. It is important to find Listeria monocytogenes and its harborage sites, if present, in their facility; and to ensure corrective actions have eliminated the pathogen and harborage sites when identified.
However, in response to their customer finding Listeria monocytogenes in their RTE finished product, a comprehensive investigation that included a root cause analysis assessing potential sources to identify and correct the cause of the contamination was not conducted. An investigation with actions such as intensified cleaning and sanitizing, intensified environmental sampling and testing, reassessment of their environmental testing program, review of sanitation procedures and monitoring records, and review of traffic patterns and equipment layout would demonstrate if all sources and potential routes of contamination have been identified and corrected.
The firm’s March 3 response outlines the corrective actions they have taken or plan to take in response to FDA finding of Listeria monocytogenes in an environmental sample. The firm’s response states that they performed a deep cleaning of several areas in their facility, performed additional environmental swabbing, and all swabs were negative for Listeria spp. However, the FDA still has concerns about the firm’s ability to adequately control Listeria monocytogenes in their facility to prevent adulteration of their RTE foods because it does not appear that they have fully investigated the cause of the contamination.
Seafood HACCPThe firm’s significant deviations are as follows:
The firm must take a corrective action in accordance with 21 CFR 123.7 whenever a verification procedure reveals the need to take a corrective action, to comply with 21 CFR 123.8(b). Section 123.7 requires that a corrective action ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation and that the cause of the deviation is corrected.
The firm did not take adequate corrective actions when the verification procedure for their finished product testing revealed the presence of Salmonella in their RTE cold smoked tuna. During a records review of their finished product testing records FDA investigators found that several lots of their RTE cold smoked tuna packaged on 7/18/2020, 7/21/2020, 7/23/2020, 7/28/2020, 9/1/2020, and 10/1/2020 were positive for Salmonella. Their records also indicated that they did not distribute these Salmonella positive lots. However, the firm’s corrective actions did not correct the cause of the deviation and ensure that no product enters commerce that is injurious to health or otherwise adulterated. This is evidenced by the reoccurrence of Salmonella in their finished products and by the following deficiencies identified from their corrective action logs. Specifically:
The firm’s 8/5/2020 corrective action log for multiple cold smoked tuna lots, packaged on 7/18/2020, 7/21/2020, 7/23/2020, and 7/28/2021 that tested positive for Salmonella, identifies the root cause as “investigation ongoing, likely a raw material (tuna) issue” and environmental swabbing as a corrective action and testing as a preventative measure. However, no corrective actions were listed that addressed their raw material of tuna. Additionally, the same lot of raw tuna used to produce these adulterated cold smoked tuna lots was also used to produce two lots of their RTE cold smoked tuna poke product, for which no finished product verification testing had been done, and were distributed. The firm’s corrective actions did not determine whether other lots of food were affected and evaluated for safety.
The firm’s 9/8/2020 corrective action for a cold smoked tuna lot packaged on 9/1/2020 again identifies the root cause as “investigation ongoing, likely a raw material — tuna — issue” and corrective actions of environmental swabbing, and acidified sodium chlorite and phage treatment on the tuna during processing; they did not provide validation information specific to the product and process. Again, no corrective actions that addressed the prevention of contamination of the raw material of tuna by the supplier were listed. After they implemented these corrective actions, tuna packaged on 10/1/2020 was found positive for Salmonella, indicating that their corrective actions were again not adequate.
The firm’s 10/7/2020 corrective action log listed the same root cause and corrective actions as their 9/8/2020 corrective action log, even after it was evident that the previous corrective actions did not prevent their RTE finished product from being adulterated with Salmonella.
Furthermore, the firm did not take adequate corrective actions in response to the verification procedure of reviewing consumer complaints. During a records review, FDA investigators found their incident report (redacted) that listed consumer illness after consuming their smoked ahi tuna reported September 8, 2020. The incident report states “Customer didn’t [sic] know you couldn’t [sic] eat raw and ended up really sick salmonella [sic]. Suggests sticker to not eat raw.” Although no lot number was reported, and no additional information was provided by the consumer, the firm told an FDA investigator they closed the complaint since all lots of the cold smoked tuna are tested for Salmonella prior to release. These corrective actions are not adequate. This report of foodborne illness from their RTE food is serious. In the event of a reported foodborne illness linked to their RTE food, FDA recommends they conduct a comprehensive investigation that includes a root cause analysis that assesses potential sources of contamination to identify and eliminate the source of the contamination. In addition, the FDA recommends they perform intensified cleaning and sanitation followed by intensified environmental sampling and testing with reassessment of their environmental testing program, sanitation procedures and monitoring records.
In response to their determination, as reflected in their corrective action logs, that the root cause of Salmonella in their cold smoked tuna was likely the raw tuna, they asked their raw tuna supplier to increase the number of samples analyzed for Salmonella from (redacted) per production date, as observed in certificates of analysis from their supplier for raw tuna with the production dates of October 7, 2020 and October 8, 2020.
This corrective action is not adequate because product testing is not an appropriate corrective action by itself for preventing contamination by pathogens. Product testing should be done as a verification procedure to verify that appropriate preventive control measures are properly implemented. Based on their root cause analysis of the raw tuna being the likely source of the Salmonella in their raw RTE finished product, appropriate corrective actions would include obtaining evidence that their raw tuna supplier made significant improvements in sanitation procedures and control measures to prevent the adulteration of RTE tuna by Salmonella. The firm’s response to this warning letter should include actions implemented to ensure all corrective actions are recorded and those corrective actions ensure no adulterated product enters commerce and the cause of the deviation is corrected.
The firm must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points. A critical control point is defined as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, the firm’s HACCP plan for Cold Smoked Ready-To-Eat Non-Scombroid Cured Fin Fish does not list a critical control point for thawing to control the hazard of pathogen growth and toxin formation as a result of time and temperature abuse. Cold smoked fish is considered a raw RTE product that must have appropriate time and temperature controls. Thus, the firm’s HACCP plan should list a critical control point for thawing that establishes critical limits and monitoring procedures that ensure that the thawing of their RTE fish occurs under refrigeration at 40 degrees F or below with continuous temperature monitoring. This is a repeat violation from two previous FDA inspections that ended on March 8, 2017, and March 12, 2020.
The need for a thawing critical control point is emphasized by our recent inspectional finding that they thawed RTE fish for six days. During a records review, our investigators found that their Production Quality Control Report (0062953) for cold smoked salmon indicated that they thawed salmon in the Cold Smoked Wet Room from Dec. 29, 2020, until Jan. 3, 2021. During the recent investigation their Cold Smoked Wet Room was observed to have ambient room temperatures around 50 degrees F.
The firm’s March 3, 2021 response states “. . . it remains our opinion that the thawing step for Cold Smoked RTE Non-Scombroid Cured Fin Fish is not a significant hazard.” Their response also states that the “internal fish temperature generally remains below 40⁰F during the thawing process. Even under extreme circumstances where fillets or raw gutted whole salmon may reach 50 degrees F, the exposure time is limited to less than 6 hours between 40 degrees F and 50 degrees F. Even when considering the potential cumulative exposure to these temperatures across multiple processing steps, we do not approach time and temperature combinations that would present a microbiological hazard.”
FDA finds this response to be not adequate. During the thawing of their RTE fish, the critical temperature is the ambient temperature of the room that the fish is exposed to, not the colder internal temperature of the fish. Because pathogens can be on the surface of the fish, FDA recommends the ambient room temperature, which directly impacts the surface of the fish, be controlled to prevent pathogen growth and toxin formation on the fish’s surface. Additionally, due to the extended time period involved (e.g., six days), thawing of their RTE fish intended for cold smoking should occur under refrigeration at 40°F or below with continuous temperature monitoring. Their response to this warning letter should include a revised HACCP plan that lists a critical control point for thawing and continuous temperature monitoring records for five batches of cold smoked fish to demonstrate proper implementation.
The firm must monitor conditions and practices during processing with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), that are appropriate to their plant and the food being processed and relate to one of the areas specified in 21 CFR 123.11(b)(1)-(8), to comply with 21 CFR 123.11(b). However, the firm did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination.
Specifically, FDA investigators observed the following:
The cold smoked wet room is used to cut all raw fish regardless if they will be cold smoked or hot smoked. After being cold smoked in “Oven 9,” RTE cold smoked products pass through the cold smoked wet room prior to being stored in “Cooler 2” and while other raw fish is being cut and processed in the room and without the room being cleaned. On Jan. 20, the firm was processing tuna in the cold smoked wet room. (Redacted) to the RTE tuna loins intended for cold smoking in the middle of the cold smoked wet room for the dry cure process. A visible (redacted) residue was observed on the floor in the room after the (redacted) tuna loins (redacted). FDA investigators later observed salmon being transferred from (redacted) for hot smoking in the same area without the area being cleaned or sanitized.
During the inspection, FDA investigators observed a drain hole cutout in the wall between the slicing room and Cooler 2, which allows water and debris to drain into Cooler 2 during cleaning and sanitation of the slicing room. On Jan. 29, cleaning and sanitation operations were observed in the slicing room. A sanitation employee was observed reaching into the slicing room drain with their gloved hands to clean the drain and then, without changing gloves, using the hose to rinse down the room and their gloved hands. After daily cleaning activities had been concluded for the slicing room, organic debris from the slicing room was observed on and next to the floor drain located in Cooler 2. A rack of in-process RTE cold smoked salmon was observed directly above the floor drain in Cooler 2. Floor drains are a common source of environmental pathogens such as Listeria monocytogenes, and movement of air, people and equipment in the area can lead to contamination of food close to the drain. Cooler 2 was not cleaned on Jan. 29 as coolers are (redacted). The cold smoked salmon was stored in the Cooler 2 until after the weekend before being moved to the slicing room for slicing.
The firm’s March 3 response states that they have reorganized tuna processing flow, implemented new routine sanitation procedures after tuna processing, retrained the sanitation team, and blocked the drain hole connecting Cooler 2 and the slicing room so debris will not be transferred from the slicing room to Cooler 2 during cleaning. The firm additionally provided a completed sanitation monitoring record for the Cold Smoked Wet Room for the week on Feb. 8. The FDA will verify the adequacy of their implemented corrective actions during their next inspection.
Current Good Manufacturing PracticeThe firm did not maintain their plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated. During the inspection FDA investigators observed pitted floors, standing water, and walls with missing tiles in various processing locations and product coolers.
Specifically, FDA investigators observed discolored tiles, missing grout, and exposed concrete in the floor of the Cold Smoked Wet Room. A hole was observed in the floor near the (redacted) along with pitted and rough floors in the salad preparation room. FDA investigators also noted screws missing or visible holes in the metal wall molding in both the cold smoked wet room and the salad prep room. Rough and pitted floors were observed in the walkways and hallways leading into the slicing room and north pre-pack room. A large concrete patch approximately 4 feet by 8 feet was observed in the walkway between Oven 1-4 and Coolers 5 and 6. Cracked and broken wall tiles and cracked floors were observed in Cooler 2, which is used for cold smoked slicing and packaging, and Cooler 5, which is used for work-in-process cooked hot smoked product. In Cooler 9, where scombroid fish are thawed and cured, the metal wall molding was observed to be separated from the wall in two areas on the North side of the cooler. The bottom of the doors leading into and out of Cooler 9 was also observed to be frayed.
It is important to ensure the physical facilities (e.g., floors and walls) in their plant are in good repair so that they can be easily cleaned and sanitized and they do not become harborage sites for pathogens. This is critical based on the firm’s history of having pathogens detected in their finished products and environmental sampling.
The firm’s March 3 response indicates the cracks and holes have been refilled and fixed, and that they continuously monitor the floor and curbing condition with environmental sampling. They stated that they deep cleaned the cold smoked wet room, conducted other facility repairs, and performed intensified environmental sampling. The firm also stated that maintenance work orders have been created to fix the rough floors, exposed concrete, and to repair the metal molding, with an expected completion date of April 30, 2021. Although these corrective actions appear adequate to address the observations, their response does not include specific procedures or information about how they will ensure that their facility is maintained in good repair moving forward. The FDA will fully assess the adequacy of these corrective actions during the firm’s next inspection.
The full warning letter can be viewed here.
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