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WARNING LETTER

Philippine Foodtrade Corp 04/01/2016

Philippine Foodtrade Corp - 01/04/2016


Recipient:
Philippine Foodtrade Corp


United States

Issuing Office:
Los Angeles District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Import Operations Branch
Los Angeles District
Long Beach Resident Post
One World Trade Center, Suite 300
Long Beach, CA 90831
Main Phone: (562) 256-7700
Fax: (562) 256-7701 

 

WARNING LETTER
 
VIA UNITED PARCEL SERVICE
 
 
SIGNATURE REQUIRED
 
 
January 4, 2016
WL# 15-16
Mr. Demitrio M. Manibo, President
Philippine Foodtrade Corp.
2626 Malt Avenue
Commerce, CA  90040
 
Dear Mr. Manibo,
 
We inspected your seafood importer establishment, located at 2626 Malt Ave, Commerce, CA 90040 between October 21, 2015 and October 23, 2015. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123.  In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123.  If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your seafood products are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they havebeen 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.
 
Your significant violations were as follows:
 
1.    You do not have or have not implemented written verification procedures, product specifications, and an affirmative step for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation. Specifically, you failed to provide written verification procedures, product specifications, and an affirmative step for: 
 
a.   Dried Mackerel (Alumahan), Butterfly Cut; Smoked Mackerel (Tinapang Hasa Hasa), Eviscerated; and Dried Round Scad (Galunggong) Butterfly Cut, manufacturer by (b)(4), Philippines 6100
 
b.   Frozen Crab Paste, manufacturer by (b)(4), Philippines 4234
 
c.   Farm raised Boneless Smoked Milkfish, manufacturer by (b)(4), Philippines
 
Your written response to observations noted during your inspection does not adequately address the cited violations of Part 123.12 noted above. The HACCP plan you submitted for your location does not meet the requirements of Part 123. 12 – Special Requirements for Imported Products outlined in Sections (a) and (b). Additionally, you provided a ‘Certificate of Compliance’ from the manufacturer, which appears to meet the requirement of maintaining on file a copy of a written guarantee from the foreign processor, stating that the imported fish or fishery product is processed in accordance with the requirements of part 123.12 (a)(ii)(D); however, this part also requires that in addition to a written guarantee, the Importer shall maintain on file a copy, in English, of the foreign processor’s HACCP plan. You did provide a copy of the foreign processor’s HACCP plans as part of your written response to FDA 483 which we received via email on October 30th, 2015; however, the HACCP plans are not complete, and do not list all the food safety hazards that are reasonably likely to occur in the types of seafood covered by these HACCP plans.
 
We may take further action if you do not promptly correct these violations. 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," seize your product(s) and/or enjoin your firm from further violating the Act.
 
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. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States. 
 
Please send your reply to:
 
Food and Drug Administration
Attention: Daniel Solis
Director Import Operations Branch
Los Angeles District
One World Trade Center, Suite 300
Long Beach, CA 90831
 
If you have questions regarding this letter, please contact Sam Rudnitsky, Compliance Officer at (562) 256-9214.
 
Sincerely,
/S/ 
LCDR Steven Porter, Acting Director
Los Angeles District 
 
 
Cc:      
David M. Mazzera, Chief
Food and Drug Branch
California Department of Public Health
PO Box 997435
1500 Capitol Ave., MS-7602
Sacramento, CA 95899-7413