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Soterion Development, Inc. MARCS-CMS 586355 —

Delivery Method:
Via Express Delivery
Food & Beverages

Recipient Name
Mr. Gilberto Cedeno
Recipient Title
General Manager/Owner
Soterion Development, Inc.

Avenue 2nd West, David

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

AUG 19, 2019


Reference #586355

Dear Mr. Cedeno:

The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Soterion Development, Inc., Pedregal, Chirigui, Panama on May 20 & 21, 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, lnspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response sent via email on June 6, 2019. Your response included a brief description of your revised recall procedure, however it did not address the items listed on the 483. Consequently, our evaluation of your response revealed it was not adequate, as further described in this letter.

In accordance with 21 CFR 123, 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 and 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 scrombotoxin forming fish (i.e., Yellowfin tuna and Mahi-mahi) are adulterated, in that they have been prepared, packed, or held under insanitary 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 Control 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 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.G(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 Histamine-Producing Species" does not list the critical control point of storage for controlling the food safety hazard of scombrotoxin (histamine) formation. Specifically, your firm stores scombrotoxin-forming fish for up to (b)(4) hours prior to shipment. Therefore, FDA recommends a storage critical control point that ensures your scrombotoxin-forming fish are either completely and continuously surrounded by ice throughout the storage time or the product is held continuously at a cooler temperature of 40°F (4.4°C) during storage. We note that your hazard analysis dismissed the need for a storage critical control point because some fish are offloaded from the boats and shipped the same day. However, even when the fish are offloaded and shipped the same day, control of the storage temperatures are important for fresh scombrotoxin-forming fish like tuna and mahi mahi unless the total time from receipt to shipping is under four (4) hours.

For additional information on controlling the food safety hazard of scombrotoxin (histamine) formation, FDA recommends you review Chapter 7 of the Hazards Guide.

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 "Histamine-Producing Species" lists critical limits at the "(b)(4)" critical control point, that are not adequate to control the hazard of scombrotoxin (histamine) formation. Specifically, your critical limit, "(b)(4)" is not adequate. FDA recommends the 12-hour limitation be clearly framed in the critical limit as from the time of death of the fish until the time that gilled and gutted fish are placed in ice or cooling media at 40°F (4.4°C) or less.

In addition, your critical limit, "(b)(4)" is not adequate. FDA recommends that a representative sample of scombrotoxin-forming fish from the lot identifies decomposition in less than 2.5% of the fish in a sample examined by sensory means.

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 Histamine-Producing Species" lists monitoring procedures at the "(b)(4)" critical control point, that are not adequate to control scombrotoxin (histamine) formation. Specifically, your monitoring procedure of "(b)(4)" is not adequate. FDA recommends, that a minimum of 118 fish per lot be examined for decomposition, or all the fish in the lot if the lot consists of less than 118 fish.

In addition, your monitoring procedure of "(b)(4)" is not adequate. FDA recommends that a minimum of 12 fish representative of the lot at delivery should be measured for internal temperature at the time of off-loading the harvest vessel for this control strategy.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing 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 and 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 action to refuse admission of your fish and 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 facility operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation (21 CFR 123), and the current Good Manufacturing Practices 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 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.

You should direct your written reply to Rosemary Sexton, Compliance Officer, Office of Compliance, Division of Enforcement, Food Assessment and Adulteration Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Rosemary Sexton via email at rosemary.sexton@fda.hhs.gov. Please reference case# 578659 on any submissions and within the subject line of any emails to us.


William A. Correll, Jr.
Office of Compliance
Center for Food Safety
     and Applied Nutrition

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