Inspections, Compliance, Enforcement, and Criminal Investigations
Avon Seafood 08-Jul-04
Department of Health and Human Services
Public Health Service
Atlanta District Office
July 8, 2004
RETURN RECEIPT REQUESTED
Tilman R. Gray, Owner
P.O. Box 251
Avon, NC 27915
Dear Mr. Gray:
On June 14 & 15, 2004, FDA conducted an inspection of your seafood processing facility located at 1224 Harbor Road, Avon, North Carolina. During that inspection, our investigator documented serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) regulations, Title 21, Code of Federal Regualations, Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section, or to otherwise operate in accordance with the requirements of this part, renders the 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 fresh, scombrotoxin forming fish are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulations through links in FDA's home page at www.fda.gov.
The deviations of concern areas follows:
1. You must implement the record keeping system that you list in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the "Receiving" and/or "Finished Product Storage" critical control points to control the histamine formation hazard listed in your HACCP plan for fresh, scombrotoxin forming fish. Specifically, you did not have any monitoring records for the control of histamine formation in scombroid fish processed by your firm during the periods of 7/5/03 to 2/9/04, and 2/21/04 to 5/1/04. This same deficiency was noted at the time of FDA's previous inspection at your facility. In addition, many of the "Receiving" monitoring records maintained during 2/10-20/04 and 6/1-11/04 were incorrectly marked as "'No Hista Fish." Our review of your records (i.e. NORTH CAROLINA TRIP TICKET(S), storage monitoring records, and invoices) for these two time periods revealed that your firm received, processed, and shipped scombroid fish including shad, Spanish mackerel, King mackerel, and blue fish.
2. You must have a HACCP plan that at aminimum lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for fresh, scombrotoxin forming fish lists a monitoring frequency at the "Finished Product Storage" critical control point that is not adequate to control the histamine formation hazard. Specifically, your monitoring Erequency for checking the adequacy of ice surrounding the product "at time of removal from finished storage cooler for shipment" should be changed to a minimum of two visual checks daily. We acknowledge that your records show that you are indeed monitoring the adequacy, ofice twice a day.
3. Because your HACCP plan includes corrective actions, the described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for fresh, scombrotoxin forming fish at the "Finished Product Storage" critical control point is not appropriate to control the histamine formation hazard. Specifically, although ft provides for an evaluation of time and temperatures to which the fish are exposed, your firm is not monitoring the fish temperatures while in the cooler, nor does it have a temperature recording device or equivalent system in place that would enable such evaluation.
We may take further action if you do not promptly correct these violations. For instance, we may recommend that the United States bring a legal action to seize your product(s) and/or enjoin your firm from operating.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as copies of HACCP plans, and HACCP monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations, and the Good Manufacturing Practice regulations (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 Carlos A. Bonnin, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street, N.E., Atlanta, Georgia 30309. If you have questions regarding any issue in this letter, please contact Mr. Bonnin at 404-253-1277.
Mary H. Woleske, Director