| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human Services
October 20, 2011
WARNING LETTER NYK-2012-1
VIA UNITED PARCEL SERVICE
Mark Rudes, President
Beyer Lightning Fish Co. Inc.
800 Food Center Drive, Unit 117
Bronx, New York 10474
Dear Mr. Rudes:
We inspected your seafood processing facility, Beyer Lightning Fish Co. Inc. located at 800 Food Center Drive, Unit 117, Bronx, New York between September 21 and October 4, 2011. 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 canned pasteurized crabmeat and vacuum packed smoked salmon 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.
We acknowledge receipt of your letter dated October 6, 2011 in response to the FDA 483 Inspectional Observations issued to your firm on October 4, 2011. Our evaluations of your October 6, 2011 response to Observations 1, 2, and 5 found these responses to be inadequate; your responses are discussed below after each violation. We acknowledge your promised corrective actions for Observations 3, 4, 6, 7, and 8, which are not listed as violations below. We will verify the adequacy of the corrective actions for Observations 3, 4, 6, 7, and 8 in our next inspection of your firm.
Your significant violations were as follows:
1) You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure (b)(4) of at Display in the Sales Area critical control point to control Clostridium botulinum listed in your HACCP plan for smoked vacuum packed fishery products and canned pasteurized crabmeat. We note that this is a repeat observation from two previous FDA inspections at your facility in February 2009 and December 2009.
Your October 6, 2011 letter promised corrective action for the observation at the display critical control point, the response states that you do not display smoked vacuum packed fishery products and canned pasteurized crabmeat because you found that ice damages the packaging for both of these items. We note that this observation was discussed with you during the inspection on September 22, 2011. On October 4, 2011, our investigator observed a partial case containing ten vacuum-packed smoked salmon sides (with no ice present) in the display area for the duration of this day's inspection. We note that the ambient temperature of the display area on October 4,2011 was 58 degrees Fahrenheit (F).
2) 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 Clostridium botulinum when your processes for vacuum packed smoked salmon and canned pasteurized crabmeat deviated from your critical limits at the receiving and storage critical control points. Our investigator observed your last continuous monitoring chart for cooler temperature was from between November 1 and 8, 2010. We note that the temperatures on this chart ranged from approximately 37 degrees F to 70 degrees F, which shows numerous temperatures above your critical limit of (b)(4) degrees F.
Additionally, we note that on or about September 16, 2011 you received and stored 660 pounds of pasteurized crabmeat and approximately 465 pounds of vacuum-packed smoked salmon; you did not have any receiving or storage records for these products. Furthermore, our investigator found that you did not have any receiving records. Therefore, you are not able to ensure that these products met your critical limits.
Your October 6,2011 response that states the cooler was undergoing regular service and that knowing that the cooler was due for service you did not have either vacuum packed product or canned pasteurized crabmeat on hand. This response is inadequate because we observed that you received and stored vacuum packed smoked salmon and canned pasteurized crabmeat on or about September 16, 2011, and did not have any of the associated HACCP monitoring records.
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 plans for vacuum packed smoked salmon and canned pasteurized crabmeat at the receiving, storage, and display critical control point to control Clostridium botulinum are not appropriate. Your corrective action at receiving critical control point states, if the temperature exceeds (b)(4) degrees F to reject the product. Your corrective action at the storage and display critical control points states if the temperature exceeds (b)(4) degrees F for more than (b)(4) hours to destroy the product. None of these corrective actions ensure that the cause of the deviation was corrected. We note that this is a repeat observation from two previous FDA inspections at your facility in February 2009 and December 2009.
Your October 6, 2011 response is inadequate because it does not provide any changes to the corrective actions in your HACCP plan for smoked vacuum packed fishery products and canned pasteurized crabmeat. You may wish to follow the guidance in chapter 13 of the fourth edition of the Fish and Fishery Products Hazards and Controls Guidance.
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. 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 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) 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.
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,
/S/
Ronald M. Pace
District Director
New York District
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