Inspections, Compliance, Enforcement, and Criminal Investigations
Witmer Foods, Inc. 9/9/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
September 9, 2009
RETURN RECEIPT REQUESTED
Mr. Jerri L. Witmer, President
Witmer Foods, Inc.
P.O. Box 3307
La Vale, MD 21502
Dear Mr. Witmer:
We inspected your seafood processing/warehouse facility, Witmer Foods, Inc., located at 21 Lane Avenue La Vale, Maryland on May 20-21 and May 28,2009. We found that you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21,Code of Federal Regulations (CFR) 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 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 Smoked Trout; raw, unfrozen Mahi-Mahi; raw, unfrozen Tuna Fish; and pasteurized crabmeat 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 and the Seafood HACCP Regulations through links in FDA's home page at www.fda.gov.
The 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 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 a HACCP plan for your ready to eat smoked trout product to control the food safety hazard of pathogen growth and potential toxin formation, including the potential for Clostridium botulinum toxin formation in vacuum packaged smoked trout.
2. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the receiving critical control point to control for pathogen growth and scombrotoxin formation listed in your HACCP plan entitled "Scombridae & Scombrotoxin susceptible species (Tuna, Mahi, etc.)" which covers raw, fresh scombroid toxin-forming species offish such as your Mahi-Mahi and Tuna.
3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for "Scombridae & Scombrotoxin susceptible species (Tuna, Mahi, etc.)" lists critical limits at the receiving critical control point that are not appropriate because they are not consistent with the monitoring procedures you have listed in your plan at this same critical control point. Specifically, your critical limits are listed as "Temp. Abuse Above; (b)(4), "while your monitoring procedures indicate (b)(4) indications of adequate (b)(4) will not provide information associated with temperature excursions or abuses above (b)(4).
4. 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 plan for your pasteurized crab meat at the receiving critical control point is not appropriate because it does not prevent potentially adulterated product from entering into commerce. Specifically, cooling product as soon as possible at receipt, when the product has already been temperature abused during transit to your facility will not mitigate potential pathogen growth that occurred during the transit period. Moreover, the corrective actions do not correct the cause of the deviation. In addition, we suggest you assess all of your corrective action plans to ensure that the actions both prevent the distribution of adulterated products into commerce and correct the causes of the deviations. Moreover, when listing actions such as (b)(4) your firm needs to ensure that you have adequate time and temperature information on which to evaluate the safety of the products.
5. You must fully document, in records, all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of (b)(4) for pasteurized crabmeat; and raw, fresh Scombridae & Scombrotoxin susceptible species (Tuna, Mahi, etc.) at the storage critical control point to control for pathogen growth and/or scombrotoxin formation.
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 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 warehouse facility operates in compliance with the Act, the Seafood HACCP regulations, and the food Good Manufacturing Practice regulations (21 CFR 11 0). 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 U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.
Alan Taylor, Director
Maryland Department of Health and Mental Hygiene
Office of Food Protection and Consumer Health Services
6 Saint Paul Street
Baltimore, MD 21202