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WARNING LETTER

Ostrea d.o.o.


Recipient:
Ostrea d.o.o.


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 

MAR 10, 2015

WARNING LETTER

VIA EXPRESS DELIVERY

Mr. Kresimir Peradinovic, Deputy Director
Ostrea d.o.o.
Ulica Hrvatske Vlade 1
Stankovci, Zadarska 23422
HR- Croatia

Reference # 443116
  

Dear Mr. Peradinovic:

The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, Ostrea d.o.o., located at Ulica Hrvatske Vlade I, Stankovci, Zadarska on July 9 & 10, 2014. 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. On July 28, 2014, your firm provided a response to the FDA 483 in a series of emails that included documentation. However, your firm did not provide a revised version of your HACCP plan for your fish and fishery products.

FDA acknowledges that you have not yet shipped products to the United States, but that you intend to do so in the near future. Prior to shipping any products to the United States, you should make all necessary corrections and send the documentation of your corrections, as your written response to this letter, to FDA.

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 scombroid species of fish, including your sardine, mackerel, and tuna 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: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.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 in order 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 your scombroid species of fish (including your sardine, mackerel, and tuna products) that was collected during the inspection does not list a critical control point or multiple critical control points for the processing of your scombroid species of fish to control the identified food safety hazard of "histamin" (i.e., scombrotoxin (histamine) formation). Specifically our investigator observed that your firm performs processing steps under unrefrigerated conditions which cumulatively may lead to scombrotoxin (histamine) formation as a result oftime and temperature abuse. These steps include for example, storage following receipt, (b)(4) and staging in the cans prior to when the fish reach retort temperatures during the sterilization process adequate to inhibit scombrotoxin (histamine) formation (b)(4). For example, FDA recommends certain controls based on the state of the product prior to your processmg:

•    For fish that have not been previously frozen sufficiently to destroy scombrotoxin-forming bacteria:

o    The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1 °C); or

o    The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 8 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1 °C).

•    For fish that have been previously frozen sufficiently to destroy scombrotoxinforming bacteria

o    The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1 °C); or
o    The fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 24 hours, cumulatively, as long as no portion of that time is at temperatures above 70°F (21.1 °C).

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 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 your scombroid species of fish (including your sardine, mackerel, and tuna products) collected during the inspection does not list critical limits at the receiving critical control point adequate to control your identified hazard of "histamin" (i.e., scombrotoxin (histamine) formation). Our investigator observed that your firm receives some fish as fresh (i.e., not frozen). Consequently, your firm needs to ensure that the fresh fish are received under properly chilled conditions and include critical limits in your HACCP plan associated with receipt of the fresh fish. For example, FDA recommends that firms ensure that the fish are received at or below 4.4 °C and that proper temperatures are maintained for the entire duration of the transit period to the facility; or that the fish are completely surrounded by adequate ice or cooling media at the time of receipt.

In addition, our investigator observed that your firm monitors histamine and decomposition at receiving. Should your firm choose to include these elements in your HACCP plan as critical limits at receiving your firm should list numerical values for these critical limits. For example, FDA recommends:

•    histamine analysis of a representative number of fish should show less than 50ppm histamine in all fish in the sample; and
•    sensory examination of a representative sample of scombrotoxin forming fish should show decomposition (persistent and readily perceptible) in less than 2.5% of fish in the sample. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition.

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. Submission of the documentation in English will facilitate our review.

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/Icms_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 there-inspection and assessing and collecting there-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: Arma White, 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 Arma White via email at Arma.White@fda.hhs.gov. 

 

Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition