Inspections, Compliance, Enforcement, and Criminal Investigations

Royal Lagoon Seafood, Inc. 9/22/16

  

Department of Health and Human Services logo

 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX:   (615) 366-7802 

 

 

September 22, 2016
 
WARNING LETTER No. 2016-NOL-14
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Valmond M. Hammond, President
Royal Lagoon Seafood, Inc.
5208 Mobile South Street
Theodore, Alabama 36582-1604
 
Dear Mr. Hammond:
 
An investigator with the U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 5208 Mobile South Street, Theodore, Alabama, on June 28-29, 2016. 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 food, 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 seafood 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.
 
The investigator issued you a Form FDA 483, Inspectional Observations (FDA 483) on June 29, 2016, which listed the following deviations:
 
1.    Failure to implement the monitoring and recordkeeping procedure in your seafood HACCP plan for Scombroid (Histamine) Formation fish [21 CFR 123.6(b)] (FDA 483 Item 2). The investigator found you are not monitoring the temperature of incoming fish, which is a critical control point for this hazard. According to your HACCP plan, you monitor the temperature at this critical step and record it on the incoming Bill of Lading for those histamine forming products. Time and temperature abuse will highly escalate the potential of this pathogen to grow and cause consumer illness. 
 
2.    Failure for the seafood HACCP plan to list one or more critical control point which are necessary for each of the identified food safety hazard [21 CFR 123.6(c)(2)] (FDA 483 Item No. 1). Since you have metal in your processing operation, this must be addressed in your HACCP plan.
 
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 regulations (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.
 
We may take further action if you do not promptly correct these deviations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
 
You should respond in writing within 15 working days from your receipt of this letter. We are in receipt of your response dated July 9, 2016, which is not adequate to address our concerns. No data was provided to assure FDA you have taken corrective actions or that you understand the concept of HACCP implementation and the seriousness of processing histamine forming fish at your facility.
 
Section 743 of the Act [21 USC 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection which identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administration expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 USC 379j-31(a)(2)(B)]. FDA will assess and collect fees for reinspection-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 reinspection-related costs.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Kari L. Batey, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615)615) 366-7808.
 
Sincerely,
/S/ 
Ruth P. Dixon
Director
New Orleans District

 

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