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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ACPETAMAR De R.L. 11/18/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
College Park, MD 

 

November 18, 2013
 
WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Mr. Jose Vidal
President
Acpetamar De R.L.
Final Avenida Miramar
Acajutla, Sonsonate, El Salvador
 
                                                Re: # 411352
 
Dear Mr. Vidal:
 
We inspected your seafood processing facility Acpetamar De R.L., located at Final Avenida Miramar, Barrio Las Penas, Acajutla, Sonsonate, El Salvador, on April 19, 2013. 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). That inspection resulted in FDA’s issuance of a FDA-483, Inspectional Observations, listing the deviations at your firm at the conclusion of the inspection. We acknowledge receipt of your response sent via email on May 28, 2013. Your response included various documents including, letter dated May 23, 2013, revised HACCP plan, corrective action report, standard operating procedures and product specification sheet. However, our evaluation of the documentation revealed 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 fish 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 & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.  
 
The Hazards Guide can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
  
This action is based on the following serious deviations:
 
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, your firm’s revised HACCP plan for “(b)(4),” is not adequate, as follows:
 
a.       Your HACCP plan lists a critical limit for sensory/organoleptic evaluation at the “(b)(4)” critical control point that is not adequate to control scombrotoxin (histamine) formation. Specifically, the critical limit states “(b)(4)” with no critical limit value. FDA recommends a critical limit of no more than 2.5% decomposition persistent and perceptible. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition.
 
b.      Your HACCP plan does not list a critical limit for internal temperature monitoring at the dock (i.e., at the time of off-loading). As a primary processor receiving the fish directly from the harvest vessel, your firm is responsible for ensuring the fish were maintained under appropriate conditions while they were held onboard the vessels.  Consequently, in addition to sensory evaluation mentioned above, your firm needs to include an internal temperature monitoring control at the time the fish are off-loaded from the vessels. Your revised HACCP does include  “(b)(4)”; however, the plan does not identify whether this temperature is taken at the dock as the fish are unloaded; or whether this temperature is taken at your facility after the fish have been transported from the dock. Further, your firm is located about (b)(4); consequently, your plan should list a critical limit for internal temperatures at offloading from the vessel AND critical limits that address transportation conditions from the dock to your facility.
 
c.       Your HACCP plan lists a critical limit “(b)(4)” that is not adequate to control scombrotoxin (histamine) formation. Your listed critical limit does not appear to provide assurances for safe handling of fish aboard the harvest vessels. The plan does not adequately describe the (b)(4) letter and does not include the parameters your firm is intending to monitor relative to time and temperature exposures of the fish while onboard the vessels. Additionally, the harvest vessel record needs to accompany each lot of fish received from each vessel. The document should be completed by the fishermen and document safety controls aboard the vessel during that trip and signed by the most responsible person aboard the vessel. Alternatively, your firm may choose to conduct histamine testing on a representative number of fish from each harvest vessel.
 
d.      Your HACCP plan lists critical limits at the “(b)(4)” critical control point that cumulatively are not adequate to control scombrotoxin (histamine) formation. Specifically, your revised plan includes steps that are numbered from (b)(4) and lists “Product is not exposed to temperatures (b)(4) for more than (b)(4) during receiving to refrigerated storage.” Combining refrigerated storage and unrefrigerated processing steps into a single critical control point is not appropriate as a control for scombrotoxin formation unless processing conditions are identical to refrigerated storage conditions (b)(4).   During unrefrigerated processing steps, ambient temperatures are expected to exceed (b)(4); therefore, cumulative exposure times must be controlled. Unless the processing areas for (b)(4) refrigerated (b)(4), your firm will need to control the total/cumulative exposure times to unrefrigerated conditions throughout  the processing steps to ensure the products do not exceed the listed time (b)(4)
 
In addition, the refrigerated storage (b)(4) should be a separate critical control point from the other processing steps and should include monitoring procedures for continuously monitoring and recording to ensure that the cooler is maintained at (b)(4).
 
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, your firm’s revised HACCP plan lists a monitoring frequency at CCP 2 that is not adequate. 
 
Your plan lists a monitoring procedure for internal temperature at the “(b)(4)” critical control point of “(b)(4).” FDA recommends your firm measure the internal temperature of a representative number of the largest fish in each lot, concentrating on any that show signs of mishandling. We recommend measuring a minimum of 12 fish, unless there is fewer than 12 fish in the lot, in which case measure all of the fish. We further recommend randomly selecting fish from throughout the lot and increasing the number of samples based on the history of the supplier or when large lots are received.
 
3.      Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action at the ”Receiving of fresh scombrotoxin fish” critical control point for sensory evaluation states “Hold and check organoleptic; Reject deficient quality product to supplier,” which alone is not adequate. FDA recommends firms also include chilling and holding the affected lot; conducting histamine testing on a minimum of 60 fish representatively collected throughout the lot, including all fish in the lot that show evidence of decomposition; and address the root cause of the deviation. 
 
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 revised HACCP plan or plans, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan or plans, 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 applicable laws and regulations. Submission of the information in English will assist in our review.   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) or 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 HAACP 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 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.
 
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 be 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 Food and Drug Administration, Attention: Standra Purnell, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. You may send any information related to this case and/or any questions you may have regarding this letter to Ms. Purnell via email at: standra.purnell@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll, Jr.
Acting Director
Office of Compliance
Center for Food Safety
      and Applied Nutrition