- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. David H. Caslow/Mr. Adam Caslow
Recipient TitleCo-Chief Executive Officer
- Acme Smoked Fish Corp.
30 Gem Street
Brooklyn, NY 11222-2804
- Issuing Office:
- Office of Human and Animal Food Operations - East Division 1
CMS # 613859
July 12, 2021
Dear Messrs. Caslow:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) hot and cold smoked seafood processing facility located at 30 Gem Street, Brooklyn, NY 11222-2804, on January 6, 7, 11, 13, 19-21, 25, 26, 29 and February 10, 2021. During our inspection we collected finished product samples of several products and environmental samples (swabs) from various areas in your facility, including areas that are near food during processing operations and your food contact surfaces. FDA laboratory analyses of the finished product samples found the presence of Salmonella, a human pathogen, in your RTE cold smoked tuna product. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Based on our inspectional results, including review of FDA’s finished product and environmental testing and your HACCP plan, we have determined that your RTE cold smoked seafood products are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act, the seafood HACCP regulation, the CGMP & PC rule, and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483 (FDA-483), Inspectional Observations. You provided responses to the inspection and sample findings via email on March 3, 8, and 19, 2021, which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns with your current HACCP programs as further described in this letter.
Presence of pathogens in seafood
Salmonella species are not endemic to seafood; therefore, 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. Symptoms of infection can range from gastroenteritis (e.g., diarrhea, fever and stomach cramps) that is self-limiting (i.e., resolves without treatment), to chronic health problems and hospitalization with life-threating illness. Although all age groups are susceptible to Salmonella infections, young children, the elderly, and those with weakened immune systems are more likely to have severe infections. Many strains of Salmonella have a very low infective dose, making prevention critical.
On January 11, 2021, FDA collected from your facility eleven (11) finished product samples of your RTE cold smoked tuna which were on hold due to your own finished product testing detecting Salmonella. FDA analysis found Salmonella in two (2) of the eleven (11) samples of 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 your facility pending destruction. These results and our serious food safety concerns related to these findings were discussed with you during a conference call on January 22, 2021.
Prior to the issuance of this Warning Letter, the Agency updated the Whole Genome Sequencing (WGS) analysis. WGS was conducted on six (6) Salmonella isolates obtained from the FDA Sample 1153332 of cold smoked tuna finished product collected on January 11, 2021; and six (6) Salmonella isolates obtained from the FDA Sample 1153334 of cold smoked tuna finished product collected on January 11, 2021. The current WGS analysis determined that the isolates derived from your finished product samples are comprised of two (2) different strains of Salmonella. Specifically of significance, one (1) of these strains included six (6) isolates from Sample 1153332 and four (4) isolates from Sample 1153334 that were determined to be a genomic match to an import product sample of raw tuna collected by FDA from your foreign tuna supplier on February 10, 2021; and two (2) 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. We advised you of the initial WGS results via a conference call on March 18, 2021.
Your response dated March 3, 2021, includes descriptions of the corrective actions that you have taken, including updating your approved supplier program for tuna used for cold smoking. Your response states that you now require testing records, testing method, and lab credentials for raw tuna suppliers. Your response also states that you will also perform raw material pathogen testing for ingredients, including tuna and sesame seeds. Additionally, your March 8, 2021 response includes a copy of your approved supplier program, effective date of February 24, 2021, which was updated to include raw material testing by your firm using a third-party laboratory for ingredients used in your cold smoked products and corrective actions for noncompliant results. Further, your March 19, 2021 response indicates that you will no longer purchase raw tuna from a specific supplier and processor, and that you are searching for new suppliers.
Your 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 you use your previous supplier you obtain evidence that the manufacturer of your raw materials has made significant improvements in sanitation procedures and sanitation control measures to prevent adulteration by Salmonella. Additionally, we recommend your supplier program for raw tuna intended to be cold smoked include obtaining the manufacturer’s sanitation procedures and controls. You should also ensure that the manufacturer’s HACCP plan acknowledges the raw tuna is an RTE food and the HACCP plan has adequate controls to prevent pathogen growth and toxin formation. Your response to this warning letter should include a copy of your revised supplier approval program, raw material testing for tuna and sesame seeds to demonstrate implementation of your above stated corrective actions, and the HACCP plan and sanitation procedures for the manufacturer of your current source of raw tuna. Additional deficiencies with your corrective actions regarding Salmonella found in your cold smoked tuna through your own finished product testing are discussed later in this letter.
L. 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. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA laboratory analysis of the environmental sample 1083726 collected on January 6, 2021 during the production of your RTE cold smoked tuna, confirmed 1 out of 100 environmental swabs collected was positive for L. monocytogenes. The positive swab was collected from the floor area adjacent to your cooler #6 used to store RTE seafood salads and their ingredients and immediately adjacent to the hallway’s foot bath. Appropriate control of L. 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 (7) L. 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 L. monocytogenes. At this time, no additional isolates were determined to match this strain of L. monocytogenes. Additionally, WGS analysis was conducted on L. monocytogenes isolates obtained from two product samples of cold smoked nova salmon collected by FDA from your facility in 2007. The current WGS analysis determined that these isolates were a genomic match to four (4) 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. We advised you of the initial WGS results via a conference call on February 3, 2021.
Additionally, on November 16, 2020 you were notified by a customer that your hot smoked ground trout, used as an ingredient in your customer’s finished product, tested positive for L. monocytogenes. You provided your 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, L. 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 your control programs for L. monocytogenes. It is important to find L. monocytogenes and its harborage sites, if present, in your facility; and to ensure corrective actions have eliminated the pathogen and harborage sites when identified. However, in response to your customer finding L. monocytogenes in your 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 your 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.
Your March 3, 2021 response outlines the corrective actions you have taken or plan to take in response to our finding of L. monocytogenes in an environmental sample. Your response states that you performed a deep cleaning of several areas in your facility, performed additional environmental swabbing, and all swabs were negative for Listeria spp. However, we still have concerns about your firm’s ability to adequately control L. monocytogenes in your facility to prevent adulteration of your RTE foods because it does not appear that you have fully investigated the cause of the contamination.
Your significant deviations are as follows:
1. You 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). Sections 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.
You did not take adequate corrective actions when the verification procedure for your finished product testing revealed the presence of Salmonella in your RTE cold smoked tuna. During a records review of your finished product testing records our investigators found that several lots of your 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. Your records also indicated that you did not distribute these Salmonella positive lots. However, your 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 your finished products and by the following deficiencies identified from your corrective action logs. Specifically:
a. Your 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 your 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 your RTE cold smoked tuna poke product (for which no finished product verification testing had been done) and were distributed. Your corrective actions did not determine whether other lots of food were affected and evaluated for safety.
b. Your 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; you 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 you implemented these corrective actions, tuna packaged on 10/1/2020 was found positive for Salmonella, indicating that your corrective actions were again not adequate.
c. Your 10/7/2020 corrective action log listed the same root cause and corrective actions as your 9/8/2020 corrective action log, even after it was evident that the previous corrective actions did not prevent your RTE finished product from being adulterated with Salmonella.
Furthermore, you did not take adequate corrective actions in response to the verification procedure of reviewing consumer complaints. During a records review, our investigators found your incident report (b)(4) that listed consumer illness after consuming your smoked ahi tuna reported September 8, 2020. The incident report states “Customer didnt [sic] know you couldnt [sic] eat raw and ended up really sick salmonilla [sic]. Suggests sticker to not eat raw.” Although no lot number was reported, and no additional information was provided by the consumer, you told our investigator you 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 your RTE food is serious. In the event of a reported foodborne illness linked to your RTE food, FDA recommends you 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, we recommend you perform intensified cleaning and sanitation followed by intensified environmental sampling and testing with reassessment of your environmental testing program, sanitation procedures and monitoring records.
In response to your determination (as reflected in your corrective action logs) that the root cause of Salmonella in your cold smoked tuna was likely the raw tuna, you asked your raw tuna supplier to increase the number of samples analyzed for Salmonella from (b)(4) per production date, as observed in certificates of analysis from your 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 your root cause analysis of the raw tuna being the likely source of the Salmonella in your raw RTE finished product, appropriate corrective actions would include obtaining evidence that your raw tuna supplier made significant improvements in sanitation procedures and control measures to prevent the adulteration of RTE tuna by Salmonella. Your 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.
2. You 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, to comply with 21 CFR Part 123.6 (a) and (c)(2). A critical control point is defined in 21 CFR Part 123.3 (b) 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, your 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, your HACCP plan should list a critical control point for thawing that establishes critical limits and monitoring procedures that ensure that the thawing of your RTE fish occurs under refrigeration at 40⁰F 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 you thawed RTE fish for six days. During a records review, our investigators found that your Production Quality Control Report (0062953) for cold smoked salmon indicated that you thawed salmon in the Cold Smoked Wet Room from December 29, 2020 until January 3, 2021. During the recent investigation your Cold Smoked Wet Room was observed to have ambient room temperatures around 50°F.
Your 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.” Your 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°F, the exposure time is limited (< 6 hours between 40 and 50°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 your 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 your RTE fish intended for cold smoking should occur under refrigeration at 40°F or below with continuous temperature monitoring. Your 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.
3. You 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 your 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, you did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination, as required by 21 CFR 117.80(c)(6). [This relates to prevention of cross-contamination from insanitary objects to food (21 CFR 123.11 (b)(3))].
Specifically, FDA investigators observed the following:
a. 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 1/20/2021, the firm was processing tuna in the Cold Smoked Wet Room. (b)(4) 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 (b)(4) residue was observed on the floor in the room after the (b)(4) tuna loins (b)(4). Our investigators later observed salmon being transferred from (b)(4) for hot smoking in the same area without the area being cleaned or sanitized.
b. During the inspection, our 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 1/29/2021, 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 L. 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 1/29/2021 as coolers are (b)(4). The cold smoked salmon was stored in the Cooler 2 until after the weekend before being moved to the slicing room for slicing.
Your March 3, 2021 response states that you have reorganized tuna processing flow, implemented new routine sanitation procedures after tuna processing, retrained the sanitation team, and you 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. You additionally provided a completed sanitation monitoring record for the Cold Smoked Wet Room for the week on February 8, 2021. We will verify the adequacy of your implemented corrective actions during your next inspection.
Current Good Manufacturing Practice (21 CFR 117, Subpart B)
1. You did not maintain your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). During the inspection our investigators observed pitted floors, standing water, and walls with missing tiles in various processing locations and product coolers.
Specifically, our 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 (b)(4) along with pitted and rough floors in the Salad Prep Room. Our 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 ft. by 8 ft. 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 your 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 your firm’s history of having pathogens detected in your finished products and environmental sampling.
Your March 3, 2021 response indicates the cracks and holes have been refilled and fixed, and that you continuously monitor the floor and curbing condition with environmental sampling. You stated that you deep cleaned the Cold Smoked Wet Room, conducted other facility repairs, and performed intensified environmental sampling. You 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, your response does not include specific procedures or information about how you will ensure that your facility is maintained in good repair moving forward. We will fully assess the adequacy of these corrective actions during your next inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing the recurrence or occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice; including, without limitation, seizure and injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Section 743 of the Act, (21 USC 379j-31), authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the reinspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within 15 working days, state the reason for the delay and the time frame within which you will do so.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, 462 Welcome Center Road, Swanton, VT 05488 or via email to email@example.com. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or firstname.lastname@example.org.
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations -
East Division 1