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WARNING LETTER

Inversiones Peru Pacifico S.A


Recipient:
Inversiones Peru Pacifico S.A


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 
5100 Paint Branch Parkway
College Park, MD 20740 

JUL 14, 2014

WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Pedro J. Inga Usca, Plant Manager
Inversiones Peru Pacifico S.A.
Calle 3 Mz D, lote,1,2,3,6 y 13
Parque, Sullana, Peru
 
Reference # 432893
 
Dear Mr. Usca:
 
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Inversiones Peru Pacifico S.A. located Calle 3, Mz D, lote,1,2,3,6 y 13, Parque Sullana, Peru on February 3-4, 2014. During that inspection, we found that you had violations of the seafood Hazard Analysis 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 observations made at your firm.
 
We acknowledge receipt of your response sent via email on March 3, 2014.  Your response included your revised HACCP plan dated February 2, 2014, blank monitoring records and a corrective action plan. However, review 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 mahi mahi 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 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.
 
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, your firm’s revised HACCP plan dated 07/02/2014 lists a critical limit that is not adequate at the “(b)(4)” critical control point to control scombrotoxin (histamine) formation. Specifically, your revised HACCP plan for “(b)(4)” lists a critical limit, “(b)(4).” 
 
FDA recommends sensory examination of a representative sample of scombrotoxin forming fish shows decomposition in less than 2.5% of the fish in the sample. For example no more than 2 fish in a sample of 118 fish may show signs of decomposition.
 
2.    You must have a HACCP plan, that at a minimum, lists monitoring procedures and their frequency, to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan dated 07/02/2014 lists monitoring procedures that are not adequate to control histamine. Specifically, at (b)(4) critical control point your plan:
 
a.    Lists at the internal temperature step “(b)(4). FDA recommends measuring the internal temperature of a representative number of the largest fish in each lot at the time of off-loading from the harvest vessel, concentrating on any fish that show signs of having been mishandled and that you measure a minimum of 12 fish unless there are fewer than 12 fish in the lot, in which case you should measure all the fish in the lot.
 
b.    Lists at histamine analysis “(b)(4).” FDA recommends that your firm test a minimum of 18 fish collected representatively throughout each lot, or the entire lot when there are fewer than 18 fish in the lot.
 
3.    Because you chose to include a corrective action plan in your revised HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However your corrective action at (b)(4) critical control point to control scombrotoxin (histamine) formation is not appropriate. Your plan states “(b)(4).”   FDA recommends that, in addition to rejecting the batch, you also discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved.
 
In addition to the above concerns, we note that your HACCP plan for your histamine fish does not include any critical control points associated with unrefrigerated processing or in-process storage. We suggest that when conducting your hazard analysis and reassessing your HACCP plan that your firm consider the need for critical control points to control histamine formation as a result of potential time and temperature abuse during unrefrigerated handling/processing and during any extended storage periods. 
 
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, 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, a copy of your process flow diagram and hazard analysis for you histamine forming fish, as well as  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.
 
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 the Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A.  If you have any questions regarding this letter, you may contact 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