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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Stonington Sea Products, LLC 2/13/13

  

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

Public Health Service
Food and Drug Administration
 
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 587-7500 
FAX: (781) 587-7556 

WARNING LETTER

CMS # 392954

         
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY


February 13, 2013


Mr. Adelbert F. Gross
Owner / Manager
Stonington Sea Products, LLC
100 N. Main Street
Stonington, ME 04681

Dear Mr. Gross:

We inspected your seafood processing facility, located at 100 North Main Street, Stonington, ME on January 14 through 18, 2013.  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 ready-to-eat (RTE), seafood products, including refrigerated ready to eat (RTE)  crabmeat 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.

Your significant violations were as follows:

1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3).  A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard."

We observed that the cooking critical limit in your HACCP plan for crabmeat is listed as “set timer to (b)(4)”, however your cook record indicates that the internal product temperature should be (b)(4)° F at the end of the cook cycle.  On January 15, 2013, we observed that internal product temperatures of crabs taken from the bottom rack were recorded between 163°, 178°, 179, 180.1° & 184°F after a (b)(4) minute cook and  re-cooking was required.  

Your cooking critical limits for RTE crabmeat should be validated to ensure that the food safety hazard of pathogenic bacteria is controlled during the cooking step.  We acknowledge receipt of your emailed response to the FDA-483 on February 8, 2013 in which you promised to conduct a validation study.   In response to this Warning Letter, you should provide documentation that this study has been completed, along with your revised HACCP plan.
    
2. You must implement the record keeping system that is 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 cooking critical control point as listed in your HACCP plans for cooked crabmeat.  For example, we noted crabmeat cooking records were not complete for at least three days, on 8/12/12, 11/10/12 and 1/12/13. 

3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4).  Your firm’s HACCP plan for crabmeat lists a monitoring procedure at the storage critical control point that is not adequate to control pathogen growth.  Your plan currently lists a visual check of the ambient air temperature (b)(4) which is not adequate to ensure that crabmeat is held at a consistently safe temperature throughout storage.  We note that you have a continuous temperature monitoring device for your cooler, however you are not checking or reviewing these monitoring records to ensure that your critical limit is not exceeded.  

4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements in 21 CFR 110, to comply with 21 CFR 123.11(b).  However, your firm did not monitor the condition and cleanliness of food contact surfaces, the prevention of cross contamination from insanitary objects, the maintenance of hand washing facilities, and the protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the following observations made by our FDA Investigator during our inspection:

• Squeegees that were used to remove excess water and crab juice from food contact work surfaces had debris of shrimp parts from the previous day's shrimp production. The same squeegee sponge-type blades were observed with broken pieces and worn out edges.
• A crab picking knife with surgical type tape over the handle was present at an employee crabmeat picking work station. The knife was not sanitized prior to being placed on the work station. 
• Ice chute had light brownish buildup.
• Hand washing sink in the cook room was made inaccessible by the storage of a rolling cart and plastic bin. 
• An employee was observed using a bimetallic stem thermometer to probe crab at the end of the cook cycle. The thermometer was placed on top of the cooker where condensate had dripped and was later observed to probe additional crabs prior to sanitization. 
• An employee was observed cleaning food containers (pans used to hold crab during cooking, tan totes used to hold cooked crabs) directly on the floor of the cook room. 
• Employees were observed using a high-pressure hose to rinse down equipment and clean floor drains including floor drains in the cooking and picking rooms. Spray water and aerosol from this activity came in contact with tan totes that are used to hold cooked crabs and air curtains that separate the processing areas.
• Condensate created as a result of steam during the cooking process was observed throughout the ceiling, vents and pipes of the cooking room. A brownish liquid dripping from the ceiling, vents and pipes  was observed dropping onto food contact surfaces and employees throughout the cooking process on January 15, 2013.

We acknowledge receipt of an email dated February 8, 2013 which included your response to the FDA-483.  Your response is unacceptable because it did not provide any documentation that these deficiencies have been corrected and there is no assurance that your proposed corrections will prevent re-occurrence. 

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.
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:  Karen N. Archdeacon, One Montvale Avenue, Stoneham, MA 02180.  If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.


Sincerely,

/S/

Amber G. Wardwell
Acting District Director
New England District Office