Foremost Foods International, Inc./Seafood City 3/13/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
March 13, 2013
WL # 28-13
William C. Go, President
Foremost Foods International, Inc.
2883 Surveyor St.
Pomona, CA 91768
Dear Mr. Go:
The Food and Drug Administration (FDA) inspected your food warehousing facility, located at 2883 Surveyor St., Pomona, CA 91768, on July 25, 2012. This inspection was conducted in response to the results of samples of your seafood products we collected from this facility on May 29, 2012. We also collected samples of your seafood products from a Seafood City Supermarket, located at 1525 Amar Rd., West Covina, CA 91792, on July 25, 2012. Based on the sample analysis for these two samples as well as additional information collected during our inspection, we have determined that your seafood products labeled as “Basa” and “Yellow Catfish” are in violation of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and its implementing regulations on FDA’s website at www.fda.gov. Specifically:
1) FDA collected sample 752818, fish labeled as “Basa” (Pangasiuis bocourti), from your facility on May 29, 2012. Laboratory analysis of this sample determined that this product is actually Pangasius hypophthalmus (acceptable market names “Swai,” “Sutchi,” “Striped Pangasius,” or “Tra”) which is a fish of inferior value. Therefore, this product is adulterated within the meaning of section 402(b)(2) of the Act in that Pangasius hypophthalmus has been substituted wholly for Pangasius bocourti. In addition, this product is misbranded under section 403(b) of the Act in that it is offered for sale under the name of Basa but is, in fact, Swai. We acknowledge that, once your firm was notified of these sample results on July 3, 2012, you promised certain corrective actions to correct these violations. However, we do not have sufficient information to evaluate the adequacy of these corrective actions. We will verify these corrective actions during our next inspection of your firm.
2) FDA collected sample 730092, fish labeled as “Yellow Catfish,” from a Seafood City Supermarket location on July 25, 2012. Your firm supplied this product to Seafood City Supermarket. The manager of the Seafood City Supermarket location stated that your firm provides all information to be included in product labels for the seafood products you supply, and that the retail store is not authorized to make any changes to that information. Laboratory analysis of this sample determined that this product is actually Clarias batrachus (acceptable market name “Walking Clarias Fish”). Therefore, this product is misbranded under section 403(t) of the Act because it is represented as catfish, but is not classified within the family Ictaluridae. Clarias batrachus is not a speciesclassified within the family Ictaluridae. Further, this product is misbranded under section 403(b) of the Act in that it is offered for sale under the name of Yellow Catfish but is, in fact, Walking Clarias Fish.
For additional information concerning FDA’s policy for acceptable market names for seafood sold in interstate commerce, see FDA’s Guidance for Industry: The Seafood List, available at: www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/ucm113260.htm.
This letter is not intended to be an all-inclusive list of the violations at your facility or with your products and their labeling. It is your responsibility to ensure compliance with all applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
In addition, FDA visited two Seafood City Supermarket locations during mid to late August 2012 to observe how seafood products that you supplied to these locations and for which you provided specific labeling information was labeled for display and sale. In particular, we observed how your “Swai” seafood products were labeled. We found that on August 18, 2012 at the West Covina Seafood City Supermarket location, Swai that you supplied and for which you provided labeling information was labeled as “Swai Catfish (Hito) Whole TW.” Furthermore, on August 21, 2012, at the Cerritos Seafood City Supermarket location Swai that you supplied and for which you provided labeling information was labeled as “Swai (Catfish) Whole Round TW” on one of the display placards in front of the iced fish. We note that, as discussed above, Swai (Pangasius hypophthalmus) cannot be legally marketed as a “Catfish.” Acceptable market names for Pangasius hypophthalmus are “Swai,” “Sutchi,” “Striped Pangasius,” or “Tra.” We ask that you revisit your promised corrections, and assure that all of your fish products marketed at your retail locations are displayed with acceptable market names only.
Please 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 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.
Your response should be sent to:
Blake Bevill, Director, Compliance Branch
FDA/Los Angeles District
Irvine, California 92612
If you have any questions about this letter please contact: David Serrano, Acting Compliance Officer at 909-390-7860 x112.
Alonza E. Cruse, Director
Los Angeles District
Patrick Kennelly, Acting Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413
Attn: FDA Correspondence