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  5. Graham Shrimp Co., Inc. - 07/15/2014
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WARNING LETTER

Graham Shrimp Co., Inc.


Recipient:
Graham Shrimp Co., Inc.


United States

Issuing Office:
New Orleans District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX:   (615) 366-7802 

 

July 15, 2014
 
WARNING LETTER NO. 2014-NOL-17
 
 
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
 
Earnest W. Anderson, Owner
Graham Shrimp Company, Inc.
13842 Shell Belt Road #B
Bayou La Batre, Alabama 36509-2348
 
Dear Mr. Anderson:
 
On May 6, 2014, an investigator with the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility located at 13842 Shell Belt Road #B, Bayou La Batre, Alabama. The inspection found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Parts 110, Good Manufacturing Practice for Human Food, and 123, Fish and Fishery Products. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan which complies with this section or otherwise operate in accordance with the requirements of 21 CFR 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (21 USC) 342(a)(4)]. Accordingly, your shrimp products are adulterated, because 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 Internet home page at www.fda.gov.
 
Your significant violations were listed on a Form FDA 483, Inspectional Observations, issued to you on May 6, 2014, and include the following:
 
1.    Failure to have a written HACCP plan which outlines controls for a food safety hazard which is reasonable likely to occur [21 CFR 123.6(b)]. The HACCP plan provided to the investigator did not contain the essential elements required to confirm with requirements of a valid plan covering current operations.
 
2.    Failure to conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards which are reasonably likely to occur for each kind of fish and fishery product your process [21 CFR 123.6(a)]. You have not conducted the appropriate hazard analysis on the different seafood products wholesaled or processed at your facility.
 
3.    Failure for your HACCP plan to be signed and dated upon initial acceptance, upon, modification, and at least annually [21 CFR 123.6(d)].
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
 
This letter will serve to acknowledge receipt of your written response, dated May 6, 2014, to the FDA 483. Your letter will become a part of our official files. Your response is inadequate as it did not contain real-time data to support proposed corrective actions already taken, and some actions have yet to be taken. Only a future inspection will determine if your firm is operating within the scope of FDA laws and regulations.
 
You should respond in writing within 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 verification records, or other useful information which would assist us in evaluation your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when your will correct any remaining violations.
 
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the Current Good Manufacturing Practice regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Please send your reply to the Food and Drug Administration, Attention: Kari L. Batey, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.
 
Sincerely,
/S/ 
Thomas D. Clarida
Acting District Director
New Orleans District