Inspections, Compliance, Enforcement, and Criminal Investigations

Gadre Marine Export Pvt. Ltd. 1/16/14

  

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

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

 

January 16, 2014
 
WARNING LETTER
 
 
VIA EXPRESS DELIVERY
 
Arjun Gadre, Managing Director
Gadre Marine Export Pvt. Ltd.
Plot FP-1, M.I.D.C. Mirjole Block
Ratnagiri, Maharashtra 415639
India
 
Reference No. # 418122
 
Dear Mr. Gadre:
 
We inspected your seafood processing facility Gadre Marine Export Pvt. Ltd., located at Plot No. 130/1, Holiday Home Road, Chorwad, Gujarat, India on August 13 and 14, 2013.  During that inspection, we found that you had 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 responses sent via email, on August 24, 2013, and August 27, 2013.  Your responses included a revised (identified as a “corrected”) HACCP plan and additional supporting documentation.  However, the responses were 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 vacuum-packaged frozen imitation crab sticks 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. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for fish and fishery products, can be found on our web site at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/FishandFisheriesProductsHazardsandControlsGuide/default.htm
 
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 revised HACCP plan entitled “HACCP Plan Form: (b)(4),” provided with your August 24 response, does not list the critical control points of container sealing (before the pasteurization process) and cooling (after the pasteurization process) to control the food safety hazard of post-pasteurization contamination. For example:
 
a.    For container sealing, FDA recommends that firms monitor the container integrity by:
                                                             
 i.    conducting a visual (non-destructive) examination of at least one container from each sealing head at least every 30 minutes of sealing machine operation; and
ii.    conducting a detailed (destructive) examination of at least one container from each sealing head at least every 4 hours of sealing machine operation. 
 
b.    For product cooling, FDA recommends that firms monitor the presence of residual chlorine in the cooling water at least every 4 hours. This is to ensure that the chlorine has not dissipated during production.   
 
2.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan entitled “HACCP Plan Form: (b)(4),” provided with your August 24 response, lists monitoring procedures at the “(b)(4)” critical control points that are not adequate to control the identified hazards of “Pathogen survival” and “Allergen declaration …” (undeclared allergens), respectively. For example:
 
a.    Your monitoring procedures listed at the “(b)(4)” critical control point do not ensure conformance with the critical limits listed at this critical control point. Your critical limits are listed as “Minimum product core (b)(4),” while the corresponding monitoring procedures are listed as an (b)(4) check of “(b)(4).” Moreover, our investigator observed that your firm is monitoring core temperatures (i.e., End-Point Internal Product Temperature (EPIPT)) and water bath temperatures (b)(4).  Our investigator also observed that you are monitoring the belt speed rather than monitoring the (b)(4) that is listed as your critical limit.  In order to ensure conformance with your listed critical limits, your firm would need to continuously monitor the core temperature of the product using a continuous time-temperature recording device for the entire duration of the (b)(4).
 
To ensure that every package receives an adequate pasteurization process, FDA recommends setting critical limits based on the minimum (or maximum) values for all the critical factors established by a scientific study.  These critical factors may include, for example, the belt speed (for a continuous pasteurizer), the temperature of the water used for pasteurizing, initial temperature of the product, container size (pouch thickness), and product formulation.  Other critical factors that affect the rate of heating of the product may also need to be established by the study.  Alternatively, you could set a critical limit based on EPIPT, established by a scientific study.  Other critical factors that affect the rate of heating of the product may also be established by the study.
 
b.    The monitoring procedure at the “(b)(4)” critical control point does not ensure that the correct label has been applied to the finished product package to control the hazard of undeclared allergens.  FDA recommends that you visually examine one label at the beginning of production of each lot, and one label every hour thereafter on finished product packages to ensure the correct allergenic ingredients are declared.
 
3.    Corrective action plans when included in HACCP plans must be appropriate, to comply with 21 CFR 123.7(b).  However, your corrective action plans listed in your firm’s revised HACCP plan entitled “HACCP Plan Form: (b)(4)” provided with your August 24 response are not appropriate. Specifically, at the “Receipt of labeling” and “Pasteurization” critical control points your corrective action plans do not ensure that the cause of the deviation is corrected.
 
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 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.
 
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 Food and Drug Administration, Attention: Mildred Benjamin, 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. If you have any questions regarding this letter, you may contact Ms. Benjamin via email at: mildred.benjamin@fda.hhs.gov
 
Sincerely,
/S/
Charlotte A. Christin
Acting Director
Office of Compliance
Center for Food Safety   
   and Applied Nutrition

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