Inspections, Compliance, Enforcement, and Criminal Investigations
Irvington Seafood Inc. 11/7/13
Department 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
November 7, 2013
WARNING LETTER NO. 2014-NOL-03
UNITED PARCEL SERVICES
Delivery Service Requested
Kevin S. Sakprasit, President
Sakprasit Enterprises Inc. DBA Irvington Seafood Inc.
11125 Beverly Road
Irvington, Alabama 36544-2961
Dear Mr. Sakprasit:
An investigator with the U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 11125 Beverly Road, Irvington, Alabama, on August 12, 13, and September 27, 2013. We found 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 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 110. 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 (USC) 342(a)(4)]. Accordingly, your cooked, fresh picked, ready-to-eat crabmeat 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 as follows:
1) You must take corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). Sections 123.7(b) and (c) require a corrective action to ensure no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation and the cause of the deviation is corrected. However, your firm did not take a corrective action to control pathogen survival when your process for your crabmeat products deviated from your critical limit at the (b)(4) critical control point (CCP).
2) You must implement the record keeping system listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the (b)(4) CCP listed in your HACCP plan for crabmeat.
3) You must adequately monitor sanitation conditions and practices during processing, to comply with 21 CFR 123.11(b). However, your firm did not monitor exclusion of pest from the food plant and the condition and cleanliness of food contact surfaces with sufficient frequency to ensure control as evidence by:
a. As many as 12 live flies were present in the cooking/backing room during cooking/backing operations on August 12, 2013. Flies were observed in direct contact with cooked crabs, cooked crab contact surfaces, and ice use to cool cooked crabs and cooked crab parts.
b. As many as six live flies were present in the picking/packing room during picking/packing operations on August 13, 2013. Flies were observed in direct contact with cooked crabs and the picking tables and cooked crab parts.
c. Three employees cracking cooked crab claws used etched handled knives which contained a black material encrusted in the etching. Employees routinely contacted the etched handles and then contacted cooked crab claws without washing or sanitizing their hands or gloves.
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.
You should respond in writing within fifteen (15) working days from your receipt of this letter. We are in receipt of your response, dated October 8, 2013, to the Form FDA 483 issued to you on September 27, 2013. Although you began to address our concerns, you failed to provide any evidence supporting your corrective actions were implemented. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP monitoring records, or other useful information to 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 your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the CGMP regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-1(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: Mark Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero via 504-832-1290, extension 1103.
Patricia K. Schafer
New Orleans District