Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/agape-iii-12102015
Timestamp: 2019-06-26 16:57:05
Document Index: 678476883

Matched Legal Cases: ['art 123', 'art 123', '§ 342', '§ 381', '§ 379', '§ 379']

Agape III - 12/10/2015 | FDA
Agape III - 12/10/2015
Agape III 10/12/2015
Mr. Charles Crissey, Owner
Alligator Bay Marina
Way & Bains Road
PO Box 30144
Alligator Bay, Bahamas
Reference No. CMS #483384
Dear Mr. Crissey:
On June 22 and 23, 2015, a representative from the U.S. Food and Drug Administration (FDA) inspected your seafood processing vessel, Agape III located at Alligator Bay Marina, Alligator Bay, Bahamas. 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 deviations found at your firm.
We received your firm’s response to the FDA-483 sent via email on June 29, 2015. Your response included a HACCP plan for “Fresh Stone Crab Claws.” Our review of the documentation determined that the response 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 Fresh Stone Crab Claws 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 Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
1. 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 to comply with 21 CFR 123.6 (a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for “Fresh Stone Crab Claws” does not list a critical control point of “Cooling” after the Cooking Stage for controlling the food safety hazard of pathogenic bacteria.
According to your SOP for “Cooking and Preservation of Fresh Stone Crabs,” after cooking, (b)(4). Your SOP calls for (b)(4). The FDA seafood HACCP regulation does not provide the option for SOPs to replace HACCP plan controls. Your HACCP plan should include a critical control point to assure the safe cooling of the cooked claws. FDA recommends cooling the product to below 70°F (21°C) within two hours and from 70°F (21°C) to 40°F (4.4°C) within an additional four hours. Additionally, we recommend monitoring internal temperatures during the cooling step to ensure the time and temperature parameters are consistently met.
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 “Fresh Stone Crab Claws” lists a critical limit (b)(4),” which is inadequate to control the hazard of pathogenic bacteria.
Your batch cooking process outlined in your SOP for “Cooking and Preservation of Fresh Stone Crabs,” shows (b)(4), but also on (b)(4) and (b)(4). These critical factors should also be included as critical limits in your plan. Your HACCP plan should also define the end product internal temperature your process is intended to result in ((b)(4)).
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for “Fresh Stone Crab Claws” lists (b)(4).” This procedure as written is unclear and confusing which may make it difficult to follow and control pathogenic bacteria due to temperature abuse at this step. Though your plan states (b)(4) cannot be continuously documented. Your HACCP plan should establish a minimum frequency when you will monitor the presence of ice (e.g., once every two hours).
4. Because you (b)(4) in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your HACCP plan for “Fresh Stone Crab Claws” includes corrective actions (b)(4) points.
You should respond in writing within 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 HACCP plan, 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 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.
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 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 foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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 consider providing a copy of this letter to your U.S. Agent.
Please send your reply to the U.S. Food and Drug Administration, Attention: Aleta T. Flores, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: aleta.flores@fda.hhs.gov. Please reference #CMS 483384 on any submissions and within the subject line of any emails to us. You may also contact Aleta T. Flores via email if you have any questions about this letter.