- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Paul J. Whitcomb
Recipient TitlePresident and Chief Executive Officer
- Whitsons Food Service - Bronx, Corp.
1800 Motor Parkway
Islandia, NY 11749
- Issuing Office:
- Division of Human and Animal Food Operations East I
158-15 Liberty Avenue
Jamaica, NY 11433
CMS # 572255
Dear Mr. Whitcomb:
The United States Food and Drug Administration (FDA) inspected your Ready-To-Eat (RTE), salad, sandwich, and institutional meals manufacturing facility located at 1800 Motor Parkway, Islandia, NY 11749 from October 30 through November 21, 2018. During our inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, [Title 21, Code of Federal Regulations, Part 117 (21 CFR 117)] (CGMP & PC rule) and the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123). Additionally, FDA collected environmental samples from various areas in your facility, including food contact surfaces and areas that are near food during processing operations. FDA laboratory analyses of the environmental samples (i.e., swabs) identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.
We received your firm’s responses to the positive L. monocytogenes sample findings sent via email on November 4, 9, 12, 13, December 7, 9, 11, and 12, 2018, and your responses to the FDA Form-483 (FDA-483) sent via email on December 4 and 14, 2018. In addition, we received your March 29, 2019 email response to FDA’s conference call with your firm on March 14, 2019 regarding the updated Whole Genome Sequence (WGS) analysis. According to your responses, you have hired consultants, performed an investigation of the processing facility and equipment including sampling for L. monocytogenes harborage sites, cleaned and sanitized your processing environment, conducted environmental sampling and finished product testing for L. monocytogenes, developed a maintenance schedule and planned improvement program, repaired equipment and floors, updated your procedures including your environmental sampling program, reassessed all food safety plans (including your “HARPC” and Seafood HACCP plans), and conducted training. We address your responses below.
Based on FDA’s inspectional findings and the analytical results for the environmental and food samples described below, we determined that your RTE products are 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 USC 331(uu)]. Lastly, 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 section 123.6 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). Accordingly, your seafood salads are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
FDA’s inspection resulted in issuance of an FDA-483, Inspectional Observations, listing deviations found during our inspection. We are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
We found the following significant deviations:
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)
1. You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (21 U.S.C. §§ 342 or 343(w)), to comply with 21 CFR 117.135(a)(1). Specifically,
a. Your food safety plan for RTE Thai Noodle Salad and Macaroni and Cheese did not identify a preventive control for the food safety hazard of contamination of RTE products with an environmental pathogen, e.g., L. monocytogenes. These RTE products are exposed to the production environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure. Furthermore, WGS analysis revealed two (2) different strains or clusters of L. monocytogenes that have become persistent in your facility. One cluster consists of the following:
- RTE finished product sample collected in September 2017 by the U.S. Department of Agriculture, Food Safety Inspection Service (USDA-FSIS)
- Five (5) environmental samples from food contact and non-food contact surfaces collected in January 2018 by USDA-FSIS
- Environmental sample collected from the (b)(4) in your (b)(4) room (sample #916186) in February 2018 by FDA
- Environment sample collected from the (b)(4) in front of (b)(4) in the (b)(4) room (sample #1085015) in October 2018 by FDA
The other cluster consists of the following:
- RTE finished product sample collected in January 2018 by USDA-FSIS
- Two (2) environmental samples collected from food contact and non-food contact surfaces in January 2018 by USDA-FSIS
- Environmental sample collected from the (b)(4) surface of (b)(4) (sample #916186) in February 2018 by FDA
- Environmental sample collected from the (b)(4) (sample #1085015) in October 2018 by FDA
The reoccurring presence of identical strains of L. monocytogenes in your finished products and manufacturing environment indicates that niche harborage sites are present in your facility. Furthermore, these repeated findings of L. monocytogenes in your environment and RTE product should have resulted in a reanalysis of your food safety plan, as required by 21 CFR § 117.170(b)(4), and the identification of contamination of RTE products with environmental pathogens as a hazard requiring a preventive control.
Additionally, on March 14, 2019, FDA informed you that WGS analysis revealed that an additional four (4) environmental samples collected by FDA at another food manufacturing facility using equipment provided by your firm in February 2019 were found to be identical to a cluster of L. monocytogenes found persistent at your facility, specifically, the first cluster described above. Three of the four environmental swabs found positive for L. monocytogenes were collected on or near this equipment provided by your firm.
b. You did not implement your preventive controls for allergens. Your preventive controls require that your labels contain an allergen declaration. However, during our inspection we observed the manufacturing, packaging, and labeling of RTE Thai Noodle Salad, a pasta salad containing wheat and soy allergens. The label affixed to the product that was ready for distribution did not contain a list of ingredients or an appropriate allergen declaration.
Your responses dated December 4 and 14, 2018, outline the corrective actions you plan to take in response to this violation, which include hiring new consultants, and reassessing and developing your “HARPC Plan(s).” Furthermore, your response provided March 29, 2019, states that you have “Reassessed and designed an FDA compliant HARPC program”; however, you have not provided your revised food safety plan. Therefore, we are unable to assess your promised corrective actions, as we do not have sufficient information to verify the adequacy of the methods and controls you have or will implement. We will verify the adequacy of your corrective actions during a future inspection.
2. Your corrective action procedures listed in the food safety plan for your Thai Noodle Salad and Macaroni and Cheese, both in modified atmosphere packaging, at the “Chilling CCP2*” process control for cooling of cooked products to control the food safety hazard of bacterial growth and/or toxin formation were not adequate to address affected food, as required by 21 CFR 117.150(a)(2). Specifically, your corrective action procedures provided that if the product is not (b)(4) or below when taking the final temperature after (b)(4), product will be sent immediately to the freezer. You correction action procedures did not describe the steps to be taken to ensure that all affected food is evaluated for safety and all affected food is prevented from entering into commerce if you cannot ensure that the affected food is not adulterated under section 402 of the Act or misbranded under section 403(w) of the Act, to comply with 21 CFR 117.150(a)(2)(iii) and (iv).
Your December 14 response outlines the corrective actions you plan to take in response to this violation, specifically that you will reassess and design “HARPC plans” to be consistent with FDA chilling guidelines and will include corrective actions that evaluate affected product before it is allowed to enter commerce. You gave a target completion date of April 5, 2019; however, you have not provided your revised food safety plan. Therefore, we are unable to assess your promised corrective actions, as we do not have sufficient information to verify the adequacy of the methods and controls you have or will implement. We will verify the adequacy of your corrective actions during a future inspection.
3. Your process controls did not include appropriate parameters, as required by 21 CFR 117.135(c)(1). Specifically, your food safety plan entitled “FULLY COOKED NOT SHELF STABLE MEAT & POULTRY (b)(4) MEALS FOOD SAFETY PLAN” (which you apply for Thai Noodle Salad in (b)(4) packaging) listed parameters in the “CCP Master CCP2 Cooling” for the “Chilling CCP2*” specifying critical limits for chilling to start “(b)(4)” and for the product “(b)(4).” These parameters do not ensure the product is cooled quickly enough to adequately control bacterial growth and/or toxin formation during cooling. FDA recommends in the Food Code cooling from 57ºC (135ºF) to 21ºC (70°F) within 2 hours and then further cooling to 5ºC (41°F) within a total of 6 hours. The cooling time to reduce temperatures to 21ºC (70°F) is important to ensure products are cooled quickly through the optimum temperatures for growth of bacterial pathogens. You cited for “Validation of cooking and chilling CCP limits” for non-meat and poultry items the cooling parameters in Section 3-501.14 [of the Food Code] for cooling (which does not provide for cooling to be delayed as long as (b)(4)), but this was not reflected in the parameters listed for your chilling CCP, nor was it clear whether you determine that the temperature reaches 21ºC (70°F) within 2 hours, as supported by your validation documentation.
Your December 14 response states that “Reassessment and development of our HARPC(s) will include design of an adequate hazard analysis with PC (processing control) of chilling temperatures and time parameter for cooked products.” Furthermore, your March 29 response states that you have “Reassessed and designed an FDA compliant HARPC program”; however, you have not provided your revised food safety plan. Therefore, we are unable to assess your promised corrective actions, as we do not have sufficient information to verify the adequacy of the methods and controls you have or will implement. We will verify the adequacy of your corrective actions during a future inspection.
Current Good Manufacturing Practice (21 CFR 117, Subpart B)
1. Your plant was not kept in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.20(b). During our inspection, on October 30, 2018, we observed two holes in the floor of the salad room in front of the (b)(4) where exposed RTE salads are processed. These holes were swabbed (swab # 122) and found positive for L. monocytogenes.
Your December 14 response states that “maintenance schedule and planned improvement program for timely-scheduled repairs to include potential Listeria harborage sites.” Furthermore, your March 29 response states that you repaired cracks within the production rooms and implemented a “Plant Improvement Program.” However, you did not provide any documentation as evidence of your corrective actions. Therefore, we are unable to assess your promised corrective actions, as we do not have sufficient information to verify the improvements you have made or will implement. We will verify the adequacy of your corrective actions during a future inspection.
Seafood HACCP (21 CFR 123)
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan “#3 SEAFOOD HACCP – Tuna” for tuna products packaged in (b)(4) packaging lists a critical limit of “Maximum pH of Tuna Salad (b)(4)” at your “Finished Product pH” critical control point that is not adequate to control the food safety hazard of Clostridium botulinum (C. botulinum) growth and toxin formation. The critical limit does not ensure that the refrigerated finished products (e.g., tuna salad sandwich and various vegetable salads containing tuna salad) have a pH of 5.0 or less to control non-proteolytic C. botulinum during distribution. The critical limit only addresses the tuna salad pH and does not address the pH of the interface of the tuna salad with the other meal components which could increase the pH of the tuna above 5.0. FDA recommends processors conduct a scientific study to determine the appropriate critical limit for the tuna salad that will result in the finished products not exceeding a pH of 5.0. Based on the outcome of the studies, your firm may choose to develop multiple HACCP plans to reflect the variety of controls necessary for your seafood products.
Your submitted responses did not address this observation.
- You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the refrigerated storage critical control point to control the food safety hazard of pathogen growth and toxin formation including C. botulinum listed in your HACCP plan for tuna products packaged in (b)(4) packaging. Specifically, we found numerous instances where you did not have temperature monitoring records and/or incomplete records. For example, our investigators collected records demonstrating you manufactured tuna salad during the week of October 7, 2018; however, you did not have any temperature monitoring records during this time. In addition, you did not have temperature monitoring records for the following weeks:
- for the week of 09/16/2018.
- for the week of 08/12/2018.
- for the week of 06/04/2018.
- for the week of 05/28/2018.
- for the week of 05/14/2018.
- for the week of 03/26/2018.
For the following dates, your temperature monitoring records were incomplete:
- Refrigerated temperature monitoring data is missing from 7 PM Sunday to 5 AM Monday during the week of 09/25/2018.
- Refrigerated temperature monitoring data is missing from 8 AM Monday to 8 AM Wednesday during the week of 08/01/2018.
- Refrigerated temperature monitoring data is missing from 7 AM Monday to 1 PM Monday during the week of 04/23/2018.
Your submitted responses did not address this observation.
3. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control the food safety hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse when your process for RTE tuna containing products deviated from the critical limit at the refrigerated storage critical control point. Specifically,
- Your refrigerated storage temperature monitoring records show the ambient temperature of your cooler was at 42°F from 5 PM Friday until 9 AM Saturday during the week of 07/09/2018. The critical limit of your refrigerated storage cooler is listed in your HACCP plan as (b)(4)oF.
- Your refrigerated storage temperature monitoring records show the ambient temperature of your cooler was at 43°F from 2 PM Wednesday until 4 AM Thursday during the week of 06/25/2018. The critical limit of your refrigerated storage cooler is listed in your HACCP plan as (b)(4)oF.
Your submitted responses did not address this observation.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring your facility operates in compliance with the Act, the CGMP, the PC rule, the seafood HACCP regulation and other applicable laws.
You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action without further notice, including without limitation, seizure, 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 re- inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re- inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re- inspection-related costs.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, 462 Welcome Center Road, Swanton, VT 05488. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619 or firstname.lastname@example.org.
Program Division Director
Office of Human and Animal Food Operations -
East Division 1