Inspections, Compliance, Enforcement, and Criminal Investigations
Belvin Seafood Corporation 10-Aug-07
Department of Health and Human Services
Public Health Service
Baltimore District Office
August 10, 2007
Mr. Bennie H. Belvin, Owner
Belvin Seafood Corporation
9662 Ban Road
Achilles, Virginia 23001
Dear Mr. Belvin:
From May 29 - June 1, 2007 we inspected your-seafood processing facility, located at 9662 Ban Rd., Achilles, VA. We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR 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 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 Bluefish and Gizzard shad are adulterated, in that the Bluefish and Gizzard Shad have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it 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 FDA investigator provided you with a copy of the FDA 483, Inspectional Observations, which presents her evaluation of your firm's performance regarding various aspects of the HACCP requirements. The deviations were as follows:
You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish or fishery product that you process, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However your firm does not have a HACCP plan for Bluefish and Gizzard Shad to control the food safety hazard of histamine formation.
You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor the following eight area of sanitation with sufficient frequency to ensure control as evidenced by:
1. Safety of Water: You are not monitoring for backflow prevention on hoses used in the fish processing area and ice machine room; and you do not have bacteriological and chemical test results for the well water used to manufacture ice used during fish processing operations.
2. Conditions and Cleanliness of Food Contact Surfaces; You are not monitoring the conditions of your food contact surfaces, as evidenced by:
a. the fish sorting table is constructed of unsealed wood, and contains deep gouges and organic build-up including fish residues and fish scales;
b. shovels used for placing ice on fish have wooden handles and metal blades that are cracked and pitted, and one shovel has a dirty blade and hand grip containing organic build-up;
c. the bin used to store ice used during fish packing operations is constructed of unsealed wood;
d. interior wall of the ice room is constructed of wood and contains flaking paint;
e. the plastic strip curtains hanging in the doorway of the cooler and ice room are dirty and have organic build-up including mold;
f. the scale used to weigh fish during packing operations contains organic build-up and fish scales; and
g. the plastic fish baskets used during packing operations are not thoroughly cleaned and sanitized prior to operations and contain residue fish parts and fish scales.
3. Prevention of Cross Contamination: You are not monitoring for prevention of cross contamination, as evidenced by an employee observed in the ice room standing in the ice pile shoveling ice into the pick-up auger wearing boots that were dirty and contained organic buildup. The boots were not washed and sanitized prior to entering the ice pile and cat feces were observed in and around the building including walk ways and parking lots.
4. Maintenance of Hand Washing, Hand Sanitizing, and Toilet Facilities: You are not monitoring hand washing and sanitizing facilities, as evidenced by no hand washing sink or sanitizer available for employees to use prior to beginning fish packing operations.
5. Protection from Adulterants: You are not monitoring for protections from adulterants, as evidenced by:
a. overhead lights in the ice room and fish packing areas that are not protected from breaking;
b. the ice machine in the ceiling has areas of rust and pooled water that is located directly above the ice pile.
c. the ice pile contains dirt and discoloration; and
d. employees were observed drinking sodas and smoking cigarettes in the fish packing area during operations.
6. Labeling, Storage, and Use of Toxic Chemicals: You are not monitoring for the storage and use of toxic chemicals as evidenced by chemicals used to clean the ice machine, including hydrochloric acid, were observed stored on the floor of the ice room.
7. Employee Health Conditions: You are not monitoring the conditions of your employee's health, as evidenced by employees area not screened daily for their health condition prior to beginning work
8. Exclusion of Pests: You are not monitoring for the exclusion of pests, as evidenced by
a. open trash cans were observed attracting and harboring flies in the fish unloading area; and
b. cats were running freely about the unloading dock, fish packing area, cooler and freezer areas, and parking lots.
Additionally, your firm failed to have an individual who has successfully completed appropriate HACCP training, or who is otherwise qualified through job experience, as required by 21 C.F.R. 123.10.
We received your letter dated June 14, 2007 responding to the FDA-483. Your response does not adequately address the observations noted in the FDA-483.
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.
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 HACCP certification, and sanitation 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Randy F. Pack, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issue in this letter, please contact Mr. Pack at 410-779-5417.