| Public Health Service Food and Drug Administration |
| New York District 158-15 Liberty Avenue Jamaica, NY 11433 |
Department of Health and Human Services
January 4, 2010
WARNING LETTER NYK-2011-13
Via United Parcel Service
Benzion Raskin, President/Owner
Benz’s Food Products, Inc.
688 Central Avenue
Brooklyn, New York 11207-1551
Dear Mr. Raskin:
We inspected your seafood processing facility, located at 688 Central Avenue, Brooklyn, New York between October 21 and 25, 2010. 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 (21 CFR 123). 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 seafood products including but not limited to, your ready-to-eat herring 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 HACCP violations were as follows:
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 for ready-to-eat salt-cured herring fillets in oil lists critical limits for monitoring ambient air temperature and cumulative time exposure at the “Temperature at Receiving” critical control point that are not adequate to control histamine formation and pathogen growth, including C. botulinum growth and toxin formation. Your response indicates that you will now begin using dataloggers at receipt to monitor transit temperatures, however, FDA recommends that your critical limit at the receiving critical control point include a temperature upper limit (i.e., 40°F) during shipping without any time limits above the target temperature above 40°F.
• However, your firm’s HACCP plan for ready-to-eat salt-cured herring fillets in oil lists critical limits for cooler temperature and internal temperature of product at the “Refrigerated Cold Storage” critical control point that are not adequate to control pathogen growth, including C. botulinum growth and toxin formation. Specifically, your critical limit of (b)(4) is inappropriate for control of C. botulinum growth and toxin formation. The critical limit must identify the maximum storage temperature, and should not include references to maximum time above the critical temperature limits. Any evaluation of exposure time should be part of your corrective action plan, and not the critical limit.
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 ready-to-eat salt-cured herring fillets in oil lists a monitoring frequency at the “Temperature at Receiving” critical control point that is not adequate to histamine formation and pathogen growth, including C. botulinum growth and toxin formation. Specifically, FDA recommends the use of continuous time temperature recording devices during transit with visual check of the instrument at least once per day.
3. Because you chose to include a corrective 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 ready-to-eat salt-cured herring fillets in oil at the “Temperature at Receiving” critical control point to control histamine formation and pathogen growth, including C. botulinum growth and toxin formation, is not appropriate. Your HACCP plan indicates that in the absence of time/temperature data, the internal product temperatures will be measured and that if the internal temperature exceeds the critical limits, product will be rejected. Since there is no internal temperature requirements outlined in the critical limits, this is an ambiguous corrective action. Also, the corrective action of “repair or replace defective monitoring devices” does not correct the problem that caused the critical limit deviation.
• However, your corrective action plan for ready-to-eat salt-cured herring fillets in oil at the “Parasite Control at Receiving” critical control point to control parasites is not appropriate. Your critical limit states that (b)(4). The corrective action for this critical limit indicates that the product will either be frozen according to critical limits or rejected at receiving. This corrective action does not state how you will address the problem that caused the critical limit deviation.
• However, your corrective action plan for ready-to-eat salt-cured herring fillets in oil at the “Parasite Control at Receiving” critical control point to also control C. botulinum, is not appropriate. Your critical limit indicates that product will contain a minimum water phase salt of (b)(4), and the corrective action states that when water phase salt is not guaranteed then reject entire lot or hold and test on a lot by lot basis. This corrective action does not state how you will address the problem that caused the critical limit deviation.
• However, your corrective action plan for ready-to-eat salt-cured herring fillets in oil at the “Refrigerated Cold Storage” critical control point to control C. botulinum, is not appropriate. Your corrective action to (b)(4) is inadequate. The corrective action does not ensure that unsafe product does not reach the consumer and does not correct the problem that caused the critical limit deviation.
4. You must maintain sanitation control records which, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c). However, your firm did not maintained sanitation monitoring records for:
• Safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice;
• Condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments;
• Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments;
• Maintenance of hand washing, hand sanitizing, and toilet facilities;
• Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological compounds;
• Proper labeling, storage, and use of toxic compounds;
• Control of employee health conditions that could result in the microbiological contamination of food, food packaging material, and food contact surfaces; and
• Exclusion of Pests from the food plant.
In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301(dd) of the Act (21 U.S.C. § 331(dd)). Our records indicate that, to date, your facility has not been registered with FDA.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. Form 3537 has been attached to this letter for your convenience. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
We acknowledge receipt of the written response dated October 29, 2010 from Sales Coordinator Shmuel Raskin. We also acknowledge receipt of the HACCP plan for salt-cured herring fillets packed in oil and monitoring records that were faxed on December 14, 2010. As described herein, FDA has concerns regarding your HACCP plan, and we note that the temperature recording charts you submitted are illegible and do not clearly show what temperatures each of the concentric circles represent, or how this relates to time intervals during monitoring.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. In your response, you should include documentation such as revised HACCP plans, monitoring records, verification that your employees are trained in seafood HACCP principals, as well as other useful information that would assist us in evaluating your corrections. In addition, please also provide an explanation of how your firm is able to measure the cumulative time and temperature exposures above your temperature critical limits based on review of your monitoring records. If you cannot complete all corrections before you respond, you should explain the reason for your delay and 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), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and Food Labeling regulation (21 CFR Part 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or Email at dean.rugnetta@fda.hhs.gov.
Sincerely,
Ronald M. Pace
District Director
New York District
cc: Shmuel Raskin, Sales Coordinator
Attachment: Form FDA 3537
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