Inspections, Compliance, Enforcement, and Criminal Investigations
Weyand Fisheries, Inc. 06-Dec-04
Department of Health and Human Services
Public Health Service
December 6, 2004
David A. Blume, President
Weyand Fisheries, Inc.
600 Biddle Ave.
Wyandotte, MI 48192
Dear Mr. Blume:
On September 1 through 13, 2004 the Food and Drug Administration (FDA) conducted an inspection of your facility located at 600 Biddle Ave., Wyandotte, MI. We found that you have serious deviations from the seafood Hazard Analysis Critical Control Point (HACCP) regulation (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan, when needed, that complies with this section or otherwise operate in accordance with the requirements of this part, readers 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 ready-to-eat pasteurized crab meat packed in hermetically sealed metal containers, mussels, and other seafood products are adulterated, in that they have been prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulation through links in FDA’s home page at www.fda.gov.
The deviations were as follows:
1) You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have 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 does not have HACCP plans for the following products:
a) Raw live refrigerated mussels to control the food safety hazards of pathogens.
b) Ready-to-eat pasteurized crabmeat to control the food safety hazard of pathogen growth and toxin formation, specifically, Clostridium botulinum. Because the product is packed in a reduced oxygen (i.e., hermetically sealed metal) container and intended to be held at refrigerated (not frozen) temperatures, Clostridium botulinum growth and toxin formation is a reasonably likely hazard. For more information on the hazard of Clostridium botulinums, please refer to Chapter 13 of FDA’s Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition.
2) You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points for each of the identified food safety hazards, in order to comply with 21 CFR 123.6(c)(2). However your HACCP plan for “Battered Shrimp” does not have a critical control point for label review to control the food safety hazard of undeclared sulfites. FDA recommends that, for shrimp products that have been treated with sulfites, firms include a critical control point in their HACCP plan to visually monitor each case or lot of labels for the presence of the sulfite declaration. This visual monitoring of one label from each case of printed labels ensures that the declaration of the sulfite is not inadvertently omitted.
3) You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 123.6(c)(4). However, your firm's HACCP plan for "Fresh Seafood Containing Histamine" lists a monitoring procedure/frequency ("[redacted]") at the cold storage critical control point that is not adequate to control the food safety hazard of histamine formation. FDA recommends continuous temperature monitoring of the cooler where ambient temperature is the sole source of cooling, and a visual check of the instrument itseIf at least once per day. For storage of raw material, in-process or finished product storage under ice or chemical cooling media, FDA recommends that the adequacy of the ice or chemical cooling media be visually checked at least twice per day.
4) Since you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for “Fresh Seafood Containing Histamine, ” “Battered Shrimp,” and “Battered Scallops” are not adequate at each of your critical control points. Your correction action plans do not list how you intend to correct the problems that caused tire critical limit deviations. An adequate corrective action plan is one that not only describes the steps to be taken to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation but also ensures that the cause of the deviation is corrected.
5) You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor conditions and cleanliness of food contact surfaces (21 CFR 123.11(b)(2)) and prevention of cross contamination (21 CFR 123.11(b)(3)) with sufficient frequency to ensure control as evidenced by:
a) Two white plastic cutting boards in the processing area were observed with deep cuts with dark brown embedded material. These same boards used for cutting fresh fish were also used for ready-to-eat fresh mussels.
b) An employee was observed filling a stainless steel bucket with batter which was sitting directly on the wet production room floor underneath the spout of the batter mixing tank. The employee then lifted the same batter filled bucket with wet bottom and held it directly over un-frozen perch fillets being carried on the conveyor belt leading to the batter cascading machine on the production line.
6) You must maintain sanitation control records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 123.11(c). However, your firm’s monitoring records do not include documentation for the monitoring of the safety of water that comes into contact with live refrigerated ready-to-eat mussels and other ready-to-eat seafood products during processing and storage. In addition, during the inspection it was observed that you did not have any sanitation monitoring records on 8/9/04.
The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment is in compliance with all requirements of the federal regulations.
You should take prompt measures to correct these deviations. Failure to promptly correct these deviations may lead to further actions such as seizure of your products and/or enjoining your firm from operations.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct these violations. You may wish to include in your response documentation (such as a HACCP Plan and copies of sanitation monitoring records) to assist us in evaluating your corrections, including an explanation to prevent reoccurrences. 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.
Your written reply should be directed to Paige E. Wilson, Compliance Officer at the above address.
Joann M. Givens
Detroit District Office