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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gulf Shrimp Co. LLC 3/24/14

  

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

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
 
WARNING LETTER
    
CMS # 421827
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
March 24, 2014
 
Mrs. Camille D. Simoneaux
Co-Owner
Gulf Shrimp Co., LLC
240 Atwater Street
Plantsville, CT 06479
                                                                                               
Dear Mrs. Simoneaux:
 
We inspected your seafood processing facility, located at 240 Atwater Street, Plantsville, Connecticut, on January 15, 2014 through January 23, 2014. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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 that complies with this section or otherwise operate in accordance with the requirements of Part 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 U.S.C. § 342(a)(4). Accordingly, your refrigerated smoked seafood products, refrigerated canned pasteurized crab meat, and histamine forming finfish, including tuna loins, are adulterated, in that 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 home page at www.fda.gov.
 
Specific violations observed during the inspection include, but are not limited to, the following:
 
1.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for all fresh pasteurized crabmeat, fresh smoked products, and ready to eat soup does not list the monitoring procedure or frequency at the “Receiving” critical control point to control Clostridium botulinum toxin formation and pathogen growth. 
 
The plan does state product temperature will be monitored with each delivery at receipt; however, this plan also states received product may also be checked for the presence of ice or cooling media. A procedure for monitoring the adequacy of ice or cooling media utilized at this critical control point is not listed.
 
2.    You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c) (7). However, your firm did not record monitoring observations at the “Cooler Storage” critical control point to control the histamine hazard listed in your HACCP plan for histamine producing species, such as fresh tuna and to control the Clostridium botulinum toxin formation and pathogen growth hazards listed in your HACCP plan for all fresh pasteurized crabmeat, fresh smoked products, and ready to eat soup.
 
Your firm was unable to provide the data logger records to demonstrate the temperatures of 40°F or less were maintained at this critical control point for the dates of (b)(4)
 
3.    Because you choose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).  However,
 
a.    Your firm’s corrective action plan for histamine producing species, such as fresh tuna, at the “Receiving” and “Cooler Storage” critical control points to control the histamine hazard, is not appropriate.  
 
Specifically, corrective action plans do not include procedures to investigate the root cause of the deviation to ensure control of the process. Furthermore, your firm’s corrective action plans at the “Cooler Storage” critical control point do not include procedures to ensure affected products are not distributed.
 
b.    Your firm’s corrective action plan for all fresh pasteurized crabmeat, fresh smoked products, and ready to eat soup at the “Cooler Storage” critical control point to control pathogen and growth of c.botulinum hazards is not appropriate.
 
Specifically, corrective action plans do not include procedures to investigate the root cause of the deviation to ensure control of the process. 
 
 
As of March 21, 2014, we have not received a response to the Form FDA 483, Inspectional Observations, issued to your firm on January 23, 2014.
 
We suggest that you use the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition to evaluate your firm’s operation regarding seafood products. While the guidance is not a binding set of requirements it does provide information that will most likely result in a HACCP plan that is acceptable to FDA. Firms may choose other control measures, but they are then responsible for scientifically establishing their adequacy. 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.
 
During review of your HACCP plans after the inspection we noted what appears to be a typographical error. The critical of  “(b)(4)”  which reads as greater than or equal to (b)(4) is frequently listed.   It is our assumption that your intention is to state “(b)(4)” and use of the greater than (b)(4) symbol not the less than (b)(4) symbol is a typographical error.   We noted this in the HACCP plan for histamine producing species at both the receiving and cooler storage CCP and in the HACCP plan for fresh pasteurized crabmeat at the cooler storage CCP. Please review plans for necessary corrections.  
 
You should 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 such as HACCP and verification records, or other useful information 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.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 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-31(a)(2)(B)). For a domestic facility, 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 Food and Drug Administration, Attention: Todd Maushart, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Maushart at 781-587-7578.
 
Sincerely,
/S/                                                                                              
Mutahar Shamsi
District Director
New England District Office
 
Cc:
 
Mr. Chad M. Simoneaux
Co-Owner
Gulf Shrimp Co., LLC
240 Atwater Street
Plantsville, CT 06479