Inspections, Compliance, Enforcement, and Criminal Investigations

Chilemar, Inc 6/29/17

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations
Division West 5 

 
 

 

UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
WARNING LETTER
 
June 29, 2017                                                                                               WL #528028-17                                                                                       
 
Eugenio Sanchez, Owner
Chilemar, Inc.
28245 Avenue Crocker, Suite 100
Valencia, CA 91355-1201
 
 
Dear Mr. Sanchez:
 
We inspected your seafood importer establishment, located at 28245 Avenue Crocker, Suite 100, Valencia, CA 91355-1201 on May 31, 2017.  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 Mahi Mahi portions and Frozen Cooked Whole Shell Mussels (Vacuum Packed)are 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 theymay 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:
 
You did not comply with 21CFR 123.12(a)(2) in that 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 adequate product specifications and an affirmative step for the following products imported in February 2017:
  • Frozen Mahi Mahi portions, Bit, Manufacturer: (b)(4).
  • Frozen Cooked Whole Shell Mussels (Vacuum Packed), Manufacturer: (b)(4).
We acknowledge that you sent a response to the above violations via FAX to the Los Angeles District Office on June 15, 2017. You indicated in your response that you were working to correct the deficiencies but were experiencing delays due to document translation issues, etc. Please include any additional responses in reference to this letter, and addressed to the personnel identified below.
 
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:
 
CDR Matthew Walburger, Acting Director, Compliance Branch
U.S. Food and Drug Administration
Human and Animal Food West 5 Compliance Branch
19701 Fairchild
Irvine, CA 92612
  
If you have questions regarding any issue in this letter, please contact Mr. Robert McNab at (949) 608-4409 or robert.mcnab@fda.hhs.gov. Please reference CMS number 528028 in your response.
 
 
Sincerely,
/S/ 
Darlene Almogela, Acting Division Director
Office of Human and Animal Food Operations
Division West 5
U.S. Food & Drug Administration
  
 
cc:      
U.S. Food and Drug Administration
Attention: Daniel Solis, Director
Office of Enforcement and Import Operations
Division of West Coast Imports
One World Trade Center, Suite 300
Long Beach, CA 90831

 

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