Inspections, Compliance, Enforcement, and Criminal Investigations
Donlan Fish & Seafoods, Inc. 3/29/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
March 29, 2013
Michael J. Donlan, President
Donlan Fish and Seafoods, Inc.
3116 Corunna Road
Flint, MI 48503-3260
Dear Mr. Donlan:
We inspected your seafood processing facility, located at 3116 Corunna Road, Flint, Michigan on February 27 through March 7, 2013. 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, the seafood products processed by your facility, including but not limited to ready-to-eat (RTE) refrigerated pasteurized crabmeat and fresh whitefish fillet products 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:
1) 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 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). However, your firm has not conducted a hazard analysis and does not have a written HACCP plan for ready-to-eat refrigerated pasteurized crabmeat to control the food safety hazard of pathogen growth.
For more information concerning the controls for pathogen growth refer to Chapter 12 of the Fish and Fishery Products Hazards & Controls Guidance.
2) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, and to comply with 21 CFR 123.11(b). However, your firm did not monitor the: safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice; condition and cleanliness of food contact surfaces; prevention of cross-contamination from insanitary objects to food; maintenance of hand washing, hand sanitizing, and toilet facilities; proper labeling, storage and use of toxic chemicals; control of employee health conditions; and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
A. On February 27 through 28, 2013, there were no backflow prevention devices installed on the hoses in the walk-in cooler and in the receiving area for the prevention of back siphonage; the drain pipe for the three-compartment sink used for washing equipment and utensils was observed with a direct connection to the sewage line with no air gap for the prevention of sewage back flow; your ice maker had rust and what appeared to be a black mold-like substance on its inner ice-contact surfaces and ice from this machine was observed coming into direct contact with fresh whitefish being processed by your firm on February 28, 2013.
B. On February 28, 2013, the white plastic cutting board being used to process raw whitefish fillets had deep cuts, crevices, and gouge marks with dark brown embedded material. The food contact surface of the cutting board also had an accumulation of dark brown embedded material in the grooves and around the heads of four screws being used to fasten it to a wooden frame underneath. The wooden frame underneath the cutting board was observed with a heavy accumulation of thick whitish/yellow buildup along most of its surfaces.
C. On February 28, 2013, the scoop end of the shovel being used to transfer ice from the ice maker to the processing room table was observed in direct contact with the processing room floor, approximately one foot away from the floor drop drain cover grate. The shovel was then observed being hung on the wall next to the ice making machine without being washed or sanitized.
D. The floor drop drain in the processing room, near the processing table, contained a thick, yellowish, putrid-smelling sludge-like material that appeared to be made up of decaying fish waste. A foul odor emanating from this drain was detectable by the investigators immediately upon entering the processing room. This drain is located approximately 2.5 feet away from the processing table where whitefish fillets were being processed on February 28, 2013, and is approximately 1.5 feet from the three-compartment sink that is used for washing and sanitizing processing equipment and utensils.
E. On February 28, 2013, an individual at your firm did not wash and sanitize his hands after each absence from the work station while processing fresh whitefish fillets. For example, this person was observed leaving the processing area, removing his gloves, exiting the building, going to the freezer building, returning to the processing room, putting on a pair of disposable gloves, and then continuing to pin bone whitefish fillets by hand.
F. On February 28, 2013, an individual at your firm was observed processing fresh whitefish fillets without wearing a hair restraint.
G. On February 28, 2013, the hand-washing facility in the processing area did not have a suitable drying device while whitefish fillets were being processed.
H. On February 27 through 28, 2013, not less than 100 previously used seafood containers and other refuse were observed strewn throughout the ambient storage area adjacent to the processing room, walk-in cooler and receiving bay. This accumulation of refuse was piled in cluttered disarray on the floor and covered an area approximately 5 feet high, 45 feet long and 10 feet wide.
In addition, the Food and Drug Administration has determined that your facility is subject to (b)(3)(A)
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) and the seafood HAACP regulation. We may also take further action to enjoin your firm from operating in violation of (b)(3)(A) and (b)(3)(A).
Please 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 plans, Hazard Analyses, 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), and (b)(3)(A). 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: Catherine Quinlan, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have questions regarding any issues in this letter, please contact Ms. Quinlan at 313-393-8153.
Art O. Czabaniuk
Acting District Director
Detroit District Office
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