- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Gustavo Alvarez
Recipient TitleGeneral Manager
- CR Grupo Comercial Alvacora S.A.
Sabana Grande de la Reinter 500 Metros Al Sur
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
August 15, 2022
Reference # 634981
Dear Mr. Gustavo Alvarez:
The United States Food and Drug Administration (FDA) conducted a Foreign Remote Regulatory Assessment (FRRA) of your seafood processing facility, CR Grupo Comercial Alvacora S.A., located at Sabana Grande de la Reinter 500 Metros Al Sur, Managua, Nicaragua, on April 18 through 22, 2022. An on‐site inspection was not possible due to travel restrictions during the COVID‐19 pandemic. During the remote assessment, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR Part 123). At the conclusion of the assessment, the FDA investigator discussed items of concern. Your firm responded to the items discussed with you at the close of the assessment on May 13, 2022, which was determined inadequate and addressed below.
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 dry sea cucumber 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 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 (CCP) to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your revised HACCP plan, dated January of 2022, for dried sea cucumbers at the drying CCP lists critical limits, of drying at (b)(4)°C ((b)(4)°F) for (b)(4) days and the final weight of the product to be (b)(4)% of the initial weight, that are not adequate to control pathogen growth and toxin formation in your shelf‐stable product. FDA recommends that your critical limits also list a target water activity of 0.85 or less in the finished product. The water activity of the finished product should be analyzed from samples collected to be representative of each batch. Alternatively, your critical limits can list the target water activity of 0.85 or less and the critical factors (e.g., minimum percent weight loss, drying temperature and time) as established by a scientific study that are needed to achieve the target water activity. With this control strategy, the testing of the water activity should be listed as a verification procedure in your HACCP plan and the analysis should be conducted at least every three months.
Additionally, your drying at (b)(4)°C ((b)(4)°F) for (b)(4) days could allow pathogen growth to reach unsafe levels before the target water activity is reached. Thus, you should either increase the drying temperature to a minimum of 57.2°C (135°F) or ensure a water activity of 0.85 or less is achieved within two hours of drying to control pathogen growth and toxin formation.
Furthermore, your drying CCP list a monitoring procedure for the critical limit of final weight of the product to be (b)(4)% of the initial weight that is not adequate. The monitoring procedure should list the recording of the weight at the beginning and at the end of drying. We acknowledge that this information is listed in the provided record template of “Drying Time Control Record for Dried Sea Cucumber PCC 3.1”, however, it should also be listed in your HACCP plan.
2. 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 HACCP plan for dried sea cucumbers at the drying CCP lists the corrective action of “(b)(4)” that is not adequate to control pathogen growth and toxin formation. Corrective actions must prevent the distribution of adulterated food into commerce and correct the cause of the deviation. FDA recommends that your corrective actions list chilling and holding the product until a food safety evaluation can be performed prior to continued drying and list actions intended to correct the cause (e.g., adjustment of temperature or humidity or reevaluation of the drying process).
1. Your “Pepino Petate” product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food. For example, the product label fails to declare a statement of identity of the food in English on the principal display panel as required by 21 CFR 101.3. Further, the product is reported to be called both “sea cucumber” and “dried sea cucumber;” however, these descriptors are not used in the name currently on your product label (translated to be “cucumber petate”).
2. Your “Pepino Petate” product is misbranded within the meaning of section 1453(a)(2) and (a)(3) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(3)] and section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] because it fails to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. See 21 CFR 101.7(b)(1). Further, we note that the term “Net. W.” is not in accordance with the abbreviations provided in 21 CFR 101.7(n).
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 Part 117, Subpart B). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should direct your written reply to Rosemary Sexton, 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 Rosemary Sexton via email at Rosemary.Sexton@fda.hhs.gov. Please reference CMS #634981 on any submissions and on the subject line of any emails to us.
Ann M. Oxenham
Office of Compliance
Center for Food Safety and Applied Nutrition