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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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17 Merrill Drive LLC 2/14/14

  

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 # 419374
 
 
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
 
February 14, 2014
 
 
Mr. John D. Petersdorf
President
17 Merrill Drive LLC
17 Merrill Drive
Rockland, ME 04841
 
Dear Mr. Petersdorf,
 
We inspected your seafood processing facility, located at 17 Merrill Drive, Rockland, ME on December 4, 5, 12, and 20, 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 vacuum-packed refrigerated and frozen ready-to-eat (RTE) lobster meat, frozen RTE scored lobster claws, refrigerated RTE crabmeat, vacuum-packed frozen RTE crabmeat, and frozen RTE scored crab claws are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, through links in FDA's home page at www.fda.gov.
 
We acknowledge the receipt of your letter, received January 24, 2014, in response to the form FDA 483, Inspectional Observations, issued to you on December 20, 2013. However, your response is not adequate in that it did not include supporting documents for our review. To determine the adequacy of your response, we will need to evaluate your complete HACCP plans in their entirety.  The deviations listed in this letter are based on the inspection and our review of your firm’s HACCP plans for vacuum-packed refrigerated and frozen RTE lobster meat, frozen RTE scored lobster claws, refrigerated RTE crabmeat, vacuum-packed frozen RTE crabmeat, and frozen RTE scored crab claws that were collected during the inspection.
 
Your significant violations are 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.” However: 
 
A.    Your firm’s HACCP plan for “lobster meat” lists a critical limit, “Product must be cooked for a minimum of (b)(4) minutes. Product must be at (b)(4) F or higher. Larger product needs to be cooked for (b)(4) minutes to a temperature of at least (b)(4) F”, at the “cooking” critical control point that is not adequate to control pathogenic bacteria survival through cooking. This critical limit has not been established by a scientific study and there is no assurance that it will eliminate or reduce this hazard to an acceptable level.
 
B.    Your firm’s HACCP plan for “crab meat” lists a critical limit, “Product must be cooked for a minimum of (b)(4) minutes. Water temperature must be at (b)(4) F or greater”, at the “cooking” critical control point that is not adequate to control pathogenic bacteria survival through cooking. This critical limit has not been established by a scientific study and there is no assurance that it will eliminate or reduce this hazard to an acceptable level.
 
C.    Your firm’s HACCP plan for “scored crab claws” lists a critical limit, “Product must be cooked for at least (b)(4) min. at (b)(4) F”, at the “cooking” critical control point that is not adequate to control pathogenic bacteria survival through cooking. This critical limit has not been established by a scientific study and there is no assurance that it will eliminate or reduce this hazard to an acceptable level.
 
D.    Your firm’s HACCP plan for “lobster meat” lists a critical limit, “Cooler must maintain a temperature of (b)(4) F or below with no more than (b)(4) minutes above (b)(4) F”, at the “high risk cooler, cooked product” critical control point that is not adequate to control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse. This critical limit allows for product to be stored above the minimum growth temperature for pathogenic bacteria.
 
E.    Your firm’s HACCP plan for “crab meat” lists a critical limit, “Cooler must maintain an average of (b)(4) F or less with no more than with no more than (b)(4) minutes above (b)(4) F”, at the “refrigerated product cooler” critical control point that is not adequate to control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse. This critical limit allows for product to be stored above the minimum growth temperature for pathogenic bacteria.
 
It is our expectation that once you have validated your process and have established new critical limits you will reassess the monitoring, recordkeeping, verification, and corrective action procedures listed in your HACCP plans at the cooking and refrigerated storage critical control points. Please review Chapter 12 of the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, which lists further guidance for controlling pathogenic bacteria growth and toxin formation as a result of time and temperature abuse. Additionally, please review Chapter 16 of the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, which lists further guidance for controlling pathogenic bacteria survival through cooking.
 
2.    You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However because your cooler is not equipped with a continuous temperature monitoring equipment:
 
A.    Your firm did not follow the monitoring procedure of (b)(4) the cooler temperature with a (b)(4) and (b)(4) at the “high risk cooler, cooked product” critical control point to control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse listed in your HACCP plan for “lobster meat”.
 
B.    Your firm did not follow the monitoring procedure of (b)(4) the cooler temperature with a (b)(4) at the “refrigerated product cooler” critical control point to control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse listed in your HACCP plan for “crab meat”.
 
3.    You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 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, and the protection of food contact surfaces from adulteration with chemical, physical, and biological contamination with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
  • Condensation from steam generated from the cooking process was observed to be dripping from the ceiling in the raw area due to inadequate exhaust/ventilation.
  • Condensation was observed on the ceilings of the ice making rooms in both the raw and high risk areas directly above totes of ice.
  • The flange area within the ceiling where ice falls through the ice chute was observed to be rusty and discolored.
  • Red cleaning hoses were observed to be in direct contact with the wet processing room floors in the raw and high risk areas when not in use.
 
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.
 
In addition, during our inspection we observed seafood products packaged in what appeared to be reduced oxygen packaging. FDA considers packaging that provides an oxygen transmission rate (in the final package) of at least 10,000 cc/m²/24 hours at 24° Celsius (C) to be oxygen permeable in relation to control of the hazard of Clostridium botulinum (C. botulinum).  Please refer to Chapter 13 of the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, which lists further guidance for controlling C. botulinum growth and toxin formation as it may apply to the types of packaging your firm utilizes.
 
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: Timothy M. Glod, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Glod at (781) 587-7473.
 
 
Sincerely,
/S/ 
Miguel A. Hernandez
Acting District Director
New England District