Inspections, Compliance, Enforcement, and Criminal Investigations
Southwind Foods LLC dba Great American Seafood Imports Co. 9/19/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
September 19, 2012
James R Elie, Vice President
Southwind Foods, LLC
DBA: Great American Seafood Imports
2900 Ayers Ave
Los Angeles, CA 90058
Dear Mr. Elie:
The Food and Drug Administration (FDA) inspected your seafood processing and repackaging facility located at 2900 Ayers Ave, Los Angeles, California between March 19 and March 28, 2012. We also collected samples of your product labeled as "SNAPPER FILL IQF (ROCKFISH)" in December 2011. Based on information obtained during our March 2012 inspection of your facility, as well as our analysis of the samples of your product and its labeling, we have determined that your "SNAPPER FILL IQF (ROCKFISH)" product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations. You can find the Act and regulations on FDA's website at www.fda.gov.
Specifically, your "SNAPPER FILL IQF (ROCKFISH)" product is adulterated within the meaning of Section 402(b)(2) of the Act [21 U.S.C. § 342(b)(2)] in that laboratory analysis has determined that Red Cod (Pseudophycis bachus, acceptable market name Morid Cod, acceptable common name Red Cod) has been substituted wholly for fish with the acceptable market names "Rockfish" or "Snapper." Furthermore, this product is misbranded within the meaning of Section 403(b) of the Act [21 U.S.C. § 343(b)] in that it is offered for sale under the name of Rockfish or Snapper but is, in fact, Red Cod. 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: http://www.fda.gov/Food/GuidanceComplianceRegulatoryinformation/GuidanceDoctnnents/Seafood/ucm113260.htm.
In addition, information about FDA's policy for snapper labeling is available in CPG Sec. 540.475 located on our website at:
Your "SNAPPER FILL IQF (ROCKFISH)" product is also misbranded within the meaning of 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that its labeling is false and misleading. Specifically, its labeling declares the presence of two different species of fish, Snapper and Rockfish, but the product is in fact Red Cod, and does not contain Snapper or Rockfish.
Furthermore, your "SNAPPER FILL IQF (ROCKFISH)" product is also misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that its label fails to declare the correct name of the species of fish, as required by section 403(w)(2) of the Act. Specifically, section 201(qq) of the Act [21 U.S.C. 321(qq)] defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils, as "major food allergens." A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, as described above, unless the label identifies the food source of the major food allergen in a certain manner. Specifically, in the case of a fish, the name of the food source from which the major food allergen is derived must include the name of the species of fish. Your product is misbranded under section 403(w) of the Act because its label identifies the species of fish as "SNAPPER FILL IQF (ROCKFISH)" when the product is in fact "Red Cod."
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
In addition, we note that your "SNAPPER FILL IQF (ROCKFISH)" product was received by your firm labeled with the country of origin of New Zealand; however, when your firm relabeled the product in November 2011, you declared the county of origin as Canada. During the March 2012 inspection, you indicated that this was a mistake and that you will correct the country of origin information on the labeling and that you voluntarily recalled one lot of this product with incorrect country of origin information. However, you did not provide any documentation to demonstrate that you have corrected this mistake. Please be aware that a food is misbranded under section 403(a)(1) of the Act if its labeling is false or misleading in any particular.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response documentation such as copies of your revised labeling or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
The above violations are not meant to be an all-inclusive list of deficiencies at your facility and on your product labels. You are responsible for ensuring that you are in compliance with all FDA regulatory requirements. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Your response should be sent to:
Dan Solis, Director
Import Operations Branch
Food and Drug Administration
222 W. 6th Street, Suite 700
San Pedro, CA 90731
If you have any questions about the content of this letter please contact: Ryan Borges, Compliance Officer, at 310-971-2287.
Alonza E. Cruse, Director
Los Angeles District
Ingeborg Small, Branch Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-741