- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Roy Cunningham
Recipient TitleCEO, COO, VP
- Macduff Shellfish -Scotland- Ltd
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park, MD 20740
April 3, 2020
Reference # 606458
Dear Mr. Cunningham:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Macduff Shellfish (Scotland) Ltd, located at Station Road, Mintlaw, Aberdeenshire, AB42 4LU, United Kingdom on December 5‐6, 2019. During that inspection, we found that you 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). At the conclusion of the inspection, the FDA investigator issued an FDA 483, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response sent via email on February 3, 2020. Your response included revised HACCP plans and corresponding HACCP documents. However, our evaluation of your response revealed it was not adequate, as further described in this letter.
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 ready‐to‐eat (RTE) frozen cooked (b)(4) packed rock crab products and ready‐to‐cook frozen lobster products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Your significant deviations are 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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). 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,
a. Your firm’s HACCP plan, entitled “Whole Brown Crab – Cooked Frozen” for your RTE frozen cooked (b)(4)‐packed whole rock crab products, does not list the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation. Your firm distributes RTE frozen cooked rock crab products in (b)(4)‐packaging. This type of packaging creates an environment which is conducive to C. botulinum growth and toxin formation. FDA recommends that your HACCP plan include appropriate controls to ensure each product is appropriately labeled with handling instructions (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”).
b. Your firm’s HACCP plan, entitled “Whole Langoustine” for your ready‐to‐cook whole frozen lobster products, does not list the food safety hazard of undeclared major food allergens and food intolerance substances (e.g., (b)(4)). Your firm receives whole raw lobsters that are treated on the (b)(4). Additionally, it was observed that your lobsters are also dipped in (b)(4)% (b)(4) solution by your firm. FDA recommends that your HACCP plan include appropriate controls to ensure all allergens and food intolerance substances (e.g., (b)(4)) are declared on the labels.
We acknowledge your response to the FDA 483 on February 3, 2020. However, your response did not include HACCP plans that identify the hazards of Clostridium botulinum for your RTE frozen cooked (b)(4) packed whole rock crab products nor the hazards of undeclared allergens for your ready‐to‐cook whole frozen lobster products. We note your firm has added sulfites to the product labels of your lobster products; however, this hazard must be addressed in your HACCP plan.
2. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogenic bacteria survival when your process for “Whole Brown Crab – Cooked Frozen” deviated from your critical limit at the ”(b)(4)” critical control point. Specifically, your firm’s HACCP plan includes a critical limit of “(b)(4)”. However, your production records indicate that on one occasion the data logger, placed inside a crab and passed through the continuous cooker unit, reached an internal temperature of (b)(4)°C for only (b)(4) seconds. There were no documented corrective action and this batch was subsequently exported to the U.S.
Your response indicates that you have drafted a new monitoring document to record “(b)(4)” that may occur during the crab cooking process. However, it is not clear from your response how you will use this record to evaluate whether the product received an adequate cook and how you will ensure the corrective action will be documented.
3. 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 “Whole Brown Crab – Cooked Frozen” at the “(b)(4)” and “(b)(4)” critical control points is not appropriate. Your corrective actions do not ensure that adulterated products do not enter commerce.
Your response included revised corrective actions that continue to be inadequate. Your corrective actions at the “(b)(4)” and “(b)(4)” critical control points rely on microbiological testing of affected product. However, the reliance on microbiological testing is not appropriate as a corrective action when a (b)(4) or (b)(4) critical limit is not met. FDA recommends that processors reject the lot or re‐cook when a (b)(4) or (b)(4) critical limit has not been met.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16‐120. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
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 Current Good Manufacturing Practice regulation (21 CFR 117 Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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 re‐inspection fees (21 U.S.C. 379j‐31(a)(2)(B)). 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.
You should direct your written reply to Marco Esteves, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS‐608), Division of Enforcement, College Park, Maryland 20740‐3835. If you have any questions regarding this letter, you may contact Marco Esteves via email at marco.esteves@FDA.hhs.gov. Please reference CMS # 606458 on any submissions and on the subject line of any emails to us.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition