5001 Campus Drive
College Park, MD 20740
MAR 15, 2017
VIA EXPRESS DELIVERY
Jorge Mancayo, Owner/CEO
Venezuela 4507 Y 16
Guayaquil, Guayas, 090150 Ecuador
Dear Mr. Mancayo:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Miyaquil SA located at Venezuela 4507 Y 16, Guayaquil, Guayas, Ecuador on November 9-10, 2016. During that inspection we found that you had 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, lnspectional Observations, listing the observations made at your firm.
We acknowledge receipt of your response sent via email on January 18, 2017. Your response included a description of your corrective measures, a HACCP plan for frozen pre-cooked clams, sanitation control records and product labels. We have evaluated the documentation and found that you have continuing serious deviations of the seafood HACCP regulation, as further explained 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 frozen pre-cooked clams 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/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.
Your significant deviations are as follows:
1. 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, the HACCP plan submitted with your January 18th response for your frozen pre-cooked clams lists a critical limit, "(b)(4)" at the Receiving critical control point, that is not adequate, by itself, to control the food safety hazard of Natural Toxins.
In addition to the critical limit for tags disclosing the certification number of the processor, FDA recommends that you ensure all molluscan shellfish were harvested from waters free of natural marine toxins.
2. 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, the HACCP plan for your frozen precooked clams lists a (b)(4), at the Processing and Cooking critical control point that is not adequate to control the food safety hazard of Pathogenic Bacteria Survival Through Cooking or Pasteurization.
Your listed procedure to monitor "cooking time and temperature" alone is not adequate to ensure that your products achieve the listed critical limits and that all product receives an adequate scheduled cook. Your HACCP plan lists cooking critical limits of (b)(4). However discussions during our investigation revealed that the clam meat is placed in a combination of boiling clam juice and water and that the meat is held in the boiling mixture for 4 minutes timed with a hand held watch.
FDA recommends the following:
i. For monitoring cook temperature and time to ensure that each piece of clam meets the critical limits of 194oF (90oC) for 3 minutes FDA recommends using a continuous temperature-recording device (e.g., a recording thermometer). The device should be installed where it measures the coldest temperature of the cooking equipment. This cold spot needs to be determined by a study. Additionally, the cook study should ensure that each pieces of meat receives an adequate cook under worse case conditions meaning that the largest and coldest piece of meat located in the coldest spot of the cooker receives a full cook. In addition, monitoring should be continuous, with a visual check of the recorded data at least once per batch. This visual check should also ensure that the critical limits have consistently been met.
ii. For monitoring that the boiling process is adequately performed to ensure that each piece of meat is exposed to a full boil for 4 minutes, FDA recommends timing the minutes once the clam juice and water mixture returns to a rolling boil after all of the meat in the batch have been added.
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, 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.
In addition to the deviations listed above, we have the following comments:
• Your HACCP plan does not list cooling after cooking as a critical control point. However, it is not clear how soon after cooking your products are placed in the freezer. Please provide additional information i.e., timeframe regarding your cooling process after cooking.
• The corrective action plans (sulfiting agents, pathogens, and natural toxins) are not appropriate, in that they do not ensure that no adulterated product enters commerce and they do not address correcting the cause of the deviation.
Additionally, Section 743 ofthe 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 there-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.
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.
Please send your reply to Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Purnell via email at email@example.com. Please reference# 518597 on any submissions and within the subject line of any emails to us.
Office of Compliance
Center for Food Safety