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  5. Sardina d.o.o. - 03/04/2015
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Sardina d.o.o.

Sardina 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
5100 Paint Branch Parkway
College Park, MD 20740 



MAR 4, 2015 
Mr. Mislov Bezmalinovic
President of the Board
Sardina d.o.o.
Ulica Ratac 1
Postira, Croatia
Reference # 445076
Dear Mr. Bezmalinovic:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Sardina d.o.o. located atUlica Ratac 1, Postira, Croatia, on July 17 to 18, 2014. During that inspection, we found that your firm had serious deviations from 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.
We acknowledge receipt of your responses sent via email on August 28, 2014, September 19, 2014, October 16, 2014, and October 17, 2014. Your response included documentation describing the corrections to the observations listed on the FDA-483, a translated HACCP plan for your firm’s fresh and frozen scombroid species products, flow diagrams, and monitoring records. However, our evaluation of the documentation revealed that your 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 scombroid species 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. 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/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
Based on our review of the inspectional findings and the documents you submitted in response to the FDA-483, we find that you have the following serious deviations:
  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 fresh and frozen scombroid species does not list the following critical control points for controlling the food safety hazard of scombrotoxin (histamine) formation:
·         Thawing of the frozen fish.
·         Storage to ensure that fresh fish are stored under adequately chilled conditions. Our investigation revealed that you firm stores in-process product for extended time periods.
·         Processing to include cumulative exposure times to unrefrigerated conditions. These may include, for example, the observed steps such as brining, rinsing, cleaning, hand stacking, evisceration/de-heading/de-tailing, pasteurizing, cooling, and any additional steps occurring when the fish are unrefrigerated, prior to when the low-acid canned food (LACF)/canned sardines reach an internal temperature of 60ºC in the retort (i.e., during the retort operation).
These critical control points hould address the time when the fish are processed at unrefrigerated ambient temperatures (i.e. temperatures exceeding 4.4°C). This may extend through multiple processing steps and your firm may choose to combine them into one processing critical control point or divide them into individual critical control points. Additionally, your firm should consider thawing times as part of the cumulative exposure times and a likely critical control point for frozen fish. Specifically, FDA recommends that your unrefrigerated processing time not exceed 12 hours, from the time your fish are removed from the freezer and are exposed to temperatures above 4.4°C until your LACF scrombroid species products reach an internal temperature of 60ºC in the retort.
  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 HACCP plan for fresh and frozen scombroid species lists a critical limit of, “The temperature of melting ice (b)(4)” at the “Receipt of Fresh and Frozen Fish” critical control point that is not adequate to control scombrotoxin (histamine) formation for fish received fresh. Specifically, a receiving temperature of b)(4) is not adequate to control excessive scombrotoxin (histamine) formation in the fresh fish (not frozen) during transit to your facility. FDA recommends that HACCP plans for fresh scombroid species fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less include the following critical limits:
    • Listing that time of transit does not exceed 4 hours including all time that the fish are out of controlled temperature environment; AND
    • Listing that internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).
    1. 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 HACCP plan for fresh and frozen scombroid species does not list monitoring procedures at the “Receipt Of Fresh And Frozen Fish” critical control point to adequately control scombrotoxin (histamine) formation. Your plan states you will take a one temperature using a “b)(4).” However, your plan does not specify whether this is internal or surface temperature of the fish. FDA recommends monitoring internal temperature for fish delivered refrigerated with a transit time of 4 hours or less. Additionally, as described above we also recommend monitoring the date and time fish were removed from a controlled temperature environment before shipment and the date and time delivered; along with the internal temperature of a representative number of fish at the time of delivery. 
    Your plan also references the temperature of melting ice. For fish delivered under ice, FDA recommends establishing critical limits that ensure fish are completely surrounded by ice at the time of delivery and monitoring the adequacy of the ice.
    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 plans; at least 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 that you have implemented the revised plan; 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.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 violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulations (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
    Please send your reply to Food and Drug Administration, Attention: Asha Dwarka, 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. Dwarka via email at: asha.dwarka@fda.hhs.gov
    William A. Correll, Jr
    Office of Compliance
    Center for Food Safety   
       and Applied Nutrition

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