|Company:||Classic Catering & Commissary Corp.|
|Subject:||CGMP for Foods/Seafood HACCP/Adulterated|
|Issuer:||New York District Office|
|Issued:||April 18, 2008||Closed:||
Department of Health and Human Services
Public Health Service
New York District
April 18, 2008
RETURN RECEIPT REQUESTED
REF: NYK 2008-11
Classic Catering & Commissary Corp.
126 East Service Road (aka 125 E. Arterial Highway)
Binghamton, New York 13901
Dear Mr. Goldman:
We inspected your seafood processing facility, located at 126 East Service Road, Binghamton, New York 13901 on December 18 and 20, 2007. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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). Accordingly, your refrigerated ready-to-eat tuna salad sandwiches are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov .
Your significant violations were as follows:
You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for refrigerated ready-to-eat tuna salad sandwiches does not list the food safety hazard of scombrotoxin formation, in addition to pathogen growth and toxin formation.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR.123.6(c)(4). However, your firm's HACCP plan for refrigerated ready-to-eat tuna salad sandwiches lists a monitoring procedure and frequency at the "Refrigerate" storage critical control point that is not adequate to control scombrotcixin formation, pathogen growth and toxin formation. Your HACCP plan lists a monitoring procedure of "room wall thermometer,"and a monitoring frequency of [redacted] daily [redacted]
Intermittent temperature checks as a monitoring procedure during extended refrigerated storage is not adequate to ensure that products are not exposed to elevated temperatures for extended time periods due to fluctuations occurring between those checks. Moreover, checking the temperatures at the beginning and and of each workday does not cover temperature monitoring during those days when you are not in operation, for example during weekends, holidays and overnight. FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated storage. In addition, we recommend a daily check ofthe recorded temperatures to ensure that proper temperatures have been maintained and a daily check of the monitoring equipment itself to ensure that it is operating properly.
3. Because you chose to include a covective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for refrigerated ready-to-eat tuna sandwiches at the "Refrigerate" critical control point to control scombrotoxin formation, pathogen growth and toxin formation is not appropriate. Your listed corrective actions, "Move to adequate cooler," does not resolve how the cause of the deviation will be corrected, or ensure that no product enters commerce that is injurious to health or is otherwise adulterated as a result of the deviation.
4. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11 (b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for: (1) safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; (2) condition and cleanliness of food contact surfaces; (3) prevention of cross-contamination from insanitary objects; (4) maintenance of hand washing and hand sanitizing; (5) protection of food, food packaging material, and food contact surfaces from adulteration; (6) proper labeling, storage and use of toxic chemicals; (7) control of employee health conditions; and (8) exclusion of pests, as required for the processing of refrigerated ready-to-eat tuna salad sandwiches from November 3, 2007 to December 20, 2007.
5. You must maintain, adequate sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However your firm did not maintain adequate sanitation monitoring records for the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; prevention of cross-contamination from insanitary objects to food and food contact surfaces, including raw product to cooked product; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; control of employee health conditions, and exclusion of pests required for the processing of refrigerated ready-to-eat tuna salad sandwiches on November 2, 2007, based on FDA's review of your sanitation audit record.
6. You must retain records at the processing facility for at least 1 year after the date they were prepared in the case of refrigerated products to comply with 21 CFR 123.9(b)(1). However, your firm's monitoring records for refrigerated ready-to-eat tuna sandwiches were only retained for three months.
We may take farther action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from yourreceipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay aid state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Anna Alexander, If you have questions regarding any issues in this letter, please contact Anna Alexander at 718-662-5683.
Otto D. Vitillo
CC: Tara M. Gianfrate
Classic Catering and Commissary Corp.
126 East Service Road (aka 125 E. Arterial Highway)
Binghamton, New York 13901