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  5. HLS Aquatic Products - 02/05/2016
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HLS Aquatic Products

HLS Aquatic Products

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 


FEB 5, 2016
Mr. Hem P. Villaluna
HLS Aquatic Products
Hiccor Compound,  Araneta Street
Bacolod City
Reference number: 486525
Dear Mr. Hem P. Villaluna:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, HLS Aquatic Products located at Hiccor Compound, Araneta Street, Singcang, Bacolod City, Philippines on September 14-15, 2015. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). That inspection resulted in FDA‘s issuance of an FDA-483, lnspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response sent via email on October 6, 2015. Your response included several documents and descriptions of corrections you have made, including a revised Hazard Analysis and HACCP plan for Dried Salted Fish. Consequently, the response 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 (FD&C Act). (21 U.S.C. § 342(a)(4)].  Accordingly, your dried salted fish products, including dried salted herring, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
We note the following significant deviations:
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 “Dried Salted Fish" list a critical limit at the Receiving critical control point that is not adequate to control scombrotoxin (histamine) formation. Specifically, the critical limits of checking the adequacy of ice and internal temperature at receipt are not adequate by themselves. As a primary processor of scombrotoxin (histamine) forming fish, we recommend that your HACCP plan include critical limits to determine if the handling conditions aboard the harvest vessel were safe. Since your plan references harvest vessel records as a control, we recommend listing a critical limit requiring the harvest vessel records from your suppliers to ensure the incoming fish were properly handled onboard the harvest vessel. An alternative method is to conduct histamine testing on a representative sample, no less than 18 fish, from each vessel load. In addition, we also recommend that you perform sensory examination of incoming fish to ensure they do not show signs of decomposition.
2.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for "Dried Salted Fish" lists a monitoring frequency at the Drying critical control point that is not adequate to control scombrotoxin (histamine) formation.  Specifically, you intend to monitor the dryer temperature before drying and every hour during drying. We recommend continuous temperature monitoring using a continuous monitoring device with a visual check of the device and record at least once per batch.
3.    Corrective action plans when included in HACCP plans must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for ''Dried Salted Fish" does not ensure that the causes of the critical limits deviations are corrected at any of your listed critical control points. In addition, at the Brining critical control point, your corrective action states, "If brine temperature is not met, add salt and ice based on formulation," for failing to meet the maximum brining temperature critical limit of (b)(4). You should also chill and hold the product until an evaluation of the time/temperature exposure is performed for the hazard of histamine formation.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation that would assist us in evaluating your corrections, such as a copy of any revised HACCP plans; at least five (5) product days' worth of monitoring records to demonstrate that you have implemented the revised plan or plans; any verification records; and any other useful information. 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 (21 CFR Part 123) is Import Alert # 16-120. This alert can be found on FDA's web site at: http://www.accessdata.fda.gov/cms_ia/importalert_25.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 current Good Manufacturing Practice regulation (21 CFR Part 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 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.
Please send your reply to the Food and Drug Administration, Attention: Brandon Bridgman, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HF -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
William A. Correll
Office of Compliance
Center for Food Safety
     and Applied Nutrition
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