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WARNING LETTER

Gamma-A Sia MARCS-CMS 481481 —


Recipient:
Gamma-A Sia


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
 College Park, MD  20740 

 

WARNING LETTER
NOV 2, 2015
 
VIA EXPRESS DELIVERY
 
Mr. Igor Kushnerchuk, Commercial Director/CEO
Gamma-A Sia
Audupes iela 15/17
Riga, Latvia LV -1030
 
Reference No. # 481481
 
Dear Mr. Kushnerchuk:
 
We inspected your seafood processing facility Gamma-A Sia located at Audepes iela 15/17, Riga, Latvia on May 14 and 15, 2015. 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 an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your emailed response dated July 6, 2015, which included retort records and heat penetration data for your canned sprats in oil, and recommend you include this data when you file your scheduled process with FDA. Your response did not address the seafood HACCP observations brought to your attention in the FDA-483. Therefore, we have continuing concerns with your canned fish products 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 various forms of canned fish 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 41h 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 4th Edition of the Hazards Guide can be found on our web site at:
 
Your significant deviations are as follows:
 
1.    You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (c) (1). A food safety hazard is defined in 21 CFR 123.3 (t) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for "Canned Smoked Fish in Oil, Canned Smoked Fish in Sauces" does not list the food safety hazards of Staphylococcus aureus (S. aureus) growth and toxin formation, and allergens.
Specifically,
 
a.  Your process flow and hazard analysis indicate that after the fish are smoked they are handled during de-heading, storage of half-finished product, packing into cans, adding dry ingredients, adding liquids, seam and code, washing closed cans and filling autoclave baskets. Your hazard analysis states that time will be controlled, but it does not indicate how much time product is exposed to temperatures that would allow for S. aureus growth and toxin formation. To prevent this hazard in your canned fish products, your HACCP plan should identify the hazard and include controls to limit the exposures of the products above 21°C to less than 3 hours from the time the fish are de-headed until the packed product is placed in the retort and retort temperature reaches 50°C.
 
b.  Your HACCP plan does not list the hazard of undeclared allergens. Finfish are considered a major allergen and one of the ingredients in your sauce is wheat, another major allergen. FDA recommends visually examining each batch of labels at the "Packaging" processing step to ensure that the labels accurately declare the allergens.
 
2.    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 "Canned Smoked Fish in Oil, Canned Smoked Fish in Sauces" does not list the critical control points for storage of the half finished product to control the food safety hazards of histamine formation and pathogen growth, including S. aureus. Specifically, your hazard analysis states that fish are stored after the smoking and de-heading steps, prior to packing into cans and being retorted. Histamine formation is possible when the smoking process is insufficient to eliminate the growth of organisms. In addition, during de-heading, the fish come into contact with equipment that was not heated with the fish and is considered significant handling which can result in recontamination of the cooked product with S. aureus which produces a heat stable toxin. Therefore, in order to control histamine and S. aureus toxin formation, storage temperatures must be controlled for the in-process product. FDA recommends storing the product at cooler ambient air temperatures of 40°F or below.
 
3.    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 "Canned Smoked Fish in Oil, Canned Smoked Fish in Sauces" lists a critical limit at the "Receiving Chilled Fish" "Receiving Frozen Fish," and "Thaw, Sort & Impale, Wash, Smoker trolley filling, Hot smoking & cooling" critical control points that is not adequate to control scombrotoxin (histamine) formation. Specifically,
 
a.  The receiving critical limit for receiving chilled fish states, "Internal Temperature max + 4.0 °C" is not adequate to control pathogen growth and histamine toxin formation during transit to your facility. FDA does not consider sampling of products for internal temperature an adequate method for determining if chilling during transport was adequate. FDA recommends that you establish a critical limit for ambient holding conditions or temperatures and ensure that all lots received are accompanied by transportation records to show that the fish were held at or below 4.44°C (40°F) throughout transit OR that the fish are fish are completely surrounded by ice at the time of delivery.
 
b.  The "Thaw, Sort & Impale, Wash, Smoker trolley filling, Hot smoking & cooling" critical control point for chilled fish and frozen fish is not adequate to control histamine formation and pathogen growth, including S. aureus.
Specifically:
 
i.  Your critical limit for chilled fish states "Fish is not exposed to temperatures above 4°C for more than 4 hours (from cooler to end of smoking process)." FDA recommends that chilled fish are not exposed to temperatures above 4.4°C for more than 4 hours from the time fish are removed from the cooler until the fish reach an internal temperature of 50°C in the retort.
ii.  Your critical limit for frozen fish states "Fish is not exposed to temperatures above 4°C for more than 12 hours (from cooler to end of smoking process). FDA recommends that frozen fish are not exposed to temperatures above 4.4°C for more than 12 hours from the time fish are removed from the cooler until the fish reach an internal temperature of 50°C in the retort.
 
4.    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(b). However, your corrective action plans for Canned Smoked Fish in Oil and Canned Smoked Fish in Sauces at the "Store Chilled Fish" critical control point to control histamine formation is not appropriate. Specifically, at the Store Chilled Fish critical control point, if your critical limit of 4 °C is exceeded, your corrective action states, in part, that "organoleptic indicators are estimated." The evaluation of organoleptic indicators can't reliably identify elevated histamine levels. FDA recommends that you chill and hold the affected product until histamine analysis is performed on a minimum of 60 fish collected from throughout each affected lot” and that you reject the lot or divert the lot to a non-food use.
 
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 violations. Your response should include documentation, such as: a copy of any revised HACCP plan or plans: at least five (5) product days worth of monitoring records (i.e., complete production days) to demonstrate that you have implemented the revised plan or plans; any verification records: and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen 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.acccssdata.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, 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. Are 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 fee 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. You should consider providing your US Agent with a copy of this letter.
 
Please send your reply to Food and Drug Administration, Attention: Brandon Bridgman, 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 Mr. Bridgman via email at Brandon.Bridgman@fda.hhs.gov
 
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition