Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, Ml 48207
August 27, 2013
Mr. David A. Blume, President
Weyand Fisheries, Inc.
600 Biddle Street
Wyandotte, Michigan 48192
Dear Mr. David A. Blume:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility Weyand Fisheries Inc., located at 471 & 600 Biddle Street, Wyandotte, Michigan, on April 11, 2013 through April 23, 2013. During that inspection, FDA found that your facility had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response sent on May 7, 2013, which included revised HACCP plans and a short summary of corrections to the observations noted on the FDA-483. Your response was inadequate as it does not completely address observations 2-a.
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, your pasteurized crab meat products are adulterated, in that they have been prepared, packed, or held under unsanitary 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. Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). Your corrective action plan listed for your Pasteurized Crab Meat provided with your May 7th response lists corrective actions when your process deviates from your critical limits at the “Receiving” and “Cold Storage” critical control points that are not adequate to control pathogens, including Clostridium botulinum growth and toxin formation.
Specifically, at the “Cold Storage” critical control point, the listed corrective action “(b)(4)” is not adequate because it is not consistent with your critical limit of 40°F listed at this same critical control point. Moreover, the corrective action does not address any action that will be taken when the product temperature is above the critical limit of (b)(4). For example, the temperature would exceed your critical limit when remaining at (b)(4) without your firm assessing the need for a corrective action. Furthermore, in addition to repairing and adjusting the cooler, we recommend that your firm either (1) chill or hold the affected product until an evaluation of the total time and temperature exposure for safety is performed; or, (2) destroy the product.
2. 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 pasteurized crab meet does not list a critical limit at the Receiving critical control point that is adequate to control Clostridium botulinum germination, growth, and toxin formation.
Specifically, your plan lists that you will take a temperature using a digital probe between containers to ensure that the products are at a critical temperature limit not to exceed 40⁰F. However, our investigation revealed that your pasteurized crab meat is in transit to your facility for an extended time period (i.e., greater than 4 hours). For products that are in transit for extended time periods, FDA recommends that firms list a critical limit and monitoring procedures that ensure the products were held at ambient temperatures of 40⁰F or below throughout entire transit period. For example, time-temperature recording devices when properly used and with adequate review of the recording data may be an appropriate control strategy. We acknowledge that you are receiving pasteurized crab meat shipments with a Time Temperature Recorder (TTR) and recording the average transit temperature on the receiving documents; however, this procedure is not documented in your HACCP plan.
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 and all applicable regulations, including the Seafood HACCP regulation and the Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking 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.
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the Food and Drug Administration, Attention: Kelli Wilkinson, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding this letter and /or information related to this case please contact me at (313) 393-8120 or via email at firstname.lastname@example.org.
Glenn T. Bass
Detroit District Office