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  5. Jh Seafood Supply Inc - 11/06/2015
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WARNING LETTER

Jh Seafood Supply Inc Nov 06, 2015

Jh Seafood Supply Inc - 11/06/2015


Recipient:
Jh Seafood Supply Inc


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
 
November 6, 2015
WL# 5-16
 
Mr. Bo Wang, Owner
Jh Seafood Supply Inc.
2001 Santa Anita A venue, Suite 202
South El Monte, CA 91733-3441
 
Dear Mr. Wang:
 
We inspected your seafood importer establishment, located at 2001 Santa Anita A venue, Suite 202 South El Monte, CA 91733 on July 8, 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 frozen shrimp is adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), 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.
 
Your significant violations were as follows:
 
1.    You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an adequate affirmative step for the frozen, raw, aquacultured shrimp from Malaysia manufactured by (b)(4).
 
•    FDA received your July 10, 2015 written response to FDA Form 483 for the raw, frozen aquacultured shrimp products you import from Malaysia. Your response indicates that your firm performed an affirmative step by maintaining a copy of the foreign processor's HACCP plan(s) and a written guarantee from the foreign processors for raw, frozen aquacultured shrimp products manufactured by (b)(4). The agency reviewed your response and found it inadequate for the reasons outlined below.
 
a.    Your firm submitted a HACCP plan for "RAW FROZEN CULTURED PRAWNS/SHRIMPS" from (b)(4), dated May 5, 2015 with your response dated July 10, 2015. The HACCP plan does not identify aquaculture drugs or sulfites as hazards in the fresh, frozen aquaculture shrimp products. The hazard analysis for frozen shrimp products from (b)(4) included in your response identified aquaculture drugs as a hazard; however your response did not include a HACCP plan as indicated in your response.
 
b.    Your firm's July 10, 2015 response includes written guarantees from (b)(4), but the guarantees from the foreign processors do not indicate that the imported seafood products were manufactured in compliance with 21 CFR 123, Seafood HACCP Regulation.
 
c.    Your response did not identify an affirmative step for raw, frozen aquacultured shrimp products from (b)(4) from Malaysia.
 
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 Samuel Rudnitsky, Compliance Officer at (562) 256-9212.
 
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