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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Crab Lady's Market 8/3/12

  

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) 596-7700 
FAX: (781) 596-7896

 

WARNING LETTER
 
CMS # 333398
 
 
VIA UPS OVERNIGHT
 
August 3, 2012
 
 
Ms. Tina M. Gray, Owner
The Crab Lady’s Market
169 Blastow Cove Road
Little Deer Isle, Maine 04650-3114
 
                                                                                               
Dear Ms. Gray
 
We inspected your seafood processing facility, located at 169 Blastow Cove Road on July 10 to July 13, 2012.  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 crabmeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 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 following critical control points listed in your HACCP plan for ready to eat crabmeat:
 
The Cooking critical control point listed in your HAACP plan states the time of the cook will be monitored visually at the end of each cook and the results will be recorded on the cook record. Your firm did not record cooking time data after 07/12/11. 
 
The Refrigerated Storage critical control point listed in your HAACP plan states the temperature of the cooler and the refrigerator will be monitored visually twice per day and the results will be recorded on the temperature monitoring chart. Your firm did not record temperature data for the cooler after 06/29/11.
 
The Picking critical control point listed in your HAACP plan states the temperature of the cooked meat will be monitored during picking and the results of the meat temperature will be recorded on the temperature records. Your firm did not record temperature data after 06/29/2011. 
 
2. 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). However, your firm’s HACCP plan for ready to eat crabmeat lists monitoring procedures and frequencies at the Refrigerated Storage critical control point that do not ensure compliance with the critical limit of 40°F or less. Monitoring the cooler and refrigerator temperature twice a day through visual inspection is not adequate to ensure in process and finished product are continuously maintained below this specific temperature. 
 
3. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water; conditions and cleanliness of food contact surfaces; prevention of cross contamination; maintenance of hand-washing, hand-sanitizing and toilet facilities; protection from adulterants; proper labeling, storage and use of toxic compounds; employee health conditions and exclusion of pests required for the processing of crabmeat after 06/16/11. 
 
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.
 
Upon further review of your HACCP plan associated with ready to eat crabmeat, we observed that your critical limit at the Cooking critical control point currently lists a minimum cook time of 20 minutes, however there is no mention of the temperature of the cook. Please review the latest edition of the Fish and Fishery Products Hazards and Controls Guidance along with your original cooking validation studies to assure that these critical limits are sufficient.  
 
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: Rory K. Geyer, Compliance Officer, U.S. Food and Drug Administration, 1 Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Geyer at 781-587-7521. 
 
                                                                                   
Sincerely,
/S/
Mutahar S. Shamsi
District Director
New England District