Inspections, Compliance, Enforcement, and Criminal Investigations

Blue Pacifico S.A.C. 8/23/16

  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

AUG 23, 2016

WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
 
Mr. Byeong Joon Nam, President
Blue Pacifico S.A.C   
Avenida Circunvalacion, Manzana A, Lote 2
Parque Industrial, Tacna, Tacna, 052 Peru
 
Reference # 501228  
 
Dear Mr. Byeong Joon Nam,
 
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Blue Pacifico S.A.C. located at Av. Circunvalacion, Manzana A, Lote 2, Parque Industrial, Tacna, Tacna, Peru on March 28-29, 2016. 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, Inspectional Observations, listing the observations made at your firm. We acknowledge receipt of your response sent via email on April 16, 2016. Your response included descriptions of corrections you have made, a revised Hazard Analysis, a revised HACCP plan titled “Plan HACCP para el procesamiento de ovas congeladas de pez volador” and other HACCP related documents. However, our evaluation of your response revealed it 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 ready-to-eat frozen flying fish roe 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 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 123.6 (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 ready-to-eat frozen flying fish roe does not list the following critical control points to control the food safety hazard of pathogen growth.
 
a.    Storage of fresh, unsalted roe after receiving. During our inspection, the FDA investigator observed that your firm stores the fresh roe prior to the start of the processing operations. Storing the raw ready-to-eat roe product under inadequate ice or inadequate refrigeration poses a potential risk for pathogen growth. FDA recommends you include a critical control point that ensures the unsalted roe is maintained continuously at 40°F (4.4°C) or below. Alternatively, if the roe is stored on ice, FDA recommends you ensure that the roe is completely surrounded in ice throughout storage.
 
b.    Unrefrigerated processing of the roe. During our inspection, the FDA investigator observed the washing, cleaning, rubbing, sieving and sorting of the roe under unrefrigerated conditions. The cumulative time for these unrefrigerated processing steps was approximately 4.5 hours. The internal temperature of the product was 71.4°F (21.9°C). This exceeds the recommended cumulative time and temperatures exposures for controlling pathogen growth.  When product exceeds 70°F (21.1°C) during unrefrigerated processing above 50°F (10°C), the time should be limited to 2 hours. FDA recommends you include a critical control point or multiple critical control points to ensure the roe is processed under adequate conditions to prevent pathogen growth. For example, we recommend a limit of 2 hours or less for the total cumulative time (i.e., including all processing steps) when the roe is exposed to unrefrigerated conditions.   
 
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 ready-to-eat frozen flying fish roe lists the critical limits at the following critical control points that are inadequate to control the food safety hazard of pathogen growth:
 
a.    At the receiving critical control point, the critical limit of “(b)(4)” is not adequate to control the hazard of pathogen growth. For products that are in transit for extended time periods (i.e., greater than 4 hours) the critical limit should ensure the products are held at 40°F (4.4°C) or less throughout the entire transit period with continuous temperature monitoring. For products in transit less than 4 hours, the critical limit should ensure transit does not to exceed 4 hours and internal temperature of the product at the time of delivery does not to exceed 40°F (4.4°C).
 
b.    At the packing critical control point, the listed critical limit of “(b)(4)” is not adequate to control for Clostridium botulinum growth and toxin formation. This declaration is not adequate because it does not include additional instructions that the product should be “thawed under refrigeration immediately before use”. FDA recommends each individual package be labeled with a statement that instructs consumers to keep the product frozen and to thaw under refrigeration (e.g., Important, keep frozen until used, thaw under refrigeration immediately before use.)
 
3.    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(a). Corrective action plans must address both the disposition of the affected products and address the cause of the deviation. At the receiving critical control point the listed corrective actions are not adequate to control for the food safety hazard of pathogen growth. The corrective actions do not address the cause of the deviation. FDA recommends the corrective actions list discontinuing the use of the supplier until evidence is obtained that the transportation practices have been corrected, in addition to rejecting the lot.
 
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.
 
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 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)). 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 send your reply to Food and Drug Administration, Attention: Philip Bermel, 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 Mr. Bermel via email at Philip.Bermel@fda.hhs.gov. Please reference #501228 on any submissions and within the subject line of any emails to us.
 
 
Sincerely,
/S/ 
William A. Correll
Director
Office of Compliance
Center for Food Safety   
   and Applied Nutrition

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