Inspections, Compliance, Enforcement, and Criminal Investigations
Grindstone Neck of Maine, LLC 9/18/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District|
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
CMS # 356398
VIA UPS OVERNIGHT
September 18, 2012
Mr. Carl R. Johnson, Owner
Grindstone Neck of Maine, LLC
311 Newman Street
Winter Harbor, ME 04693
Dear Mr. Johnson:
We inspected your seafood processing facility, located at 311 Newman St, Winter Harbor, ME on July 30 to August 10, 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 (RTE) vacuum-packed cold smoked mussels 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.
We have received your firm’s undated response letter on August 23, 2012 and note that it lacks sufficient corrective actions.
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 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."
a. Your firm’s HACCP plan for RTE vacuum-packed cold smoked mussels lists a critical limit of "1 lb. salt/gal water mfg. recipe, 5 min. cure @ 50° F" at the brining critical control point that is not adequate to control pathogen growth and toxin formation. A validation study that supports the adequacy of the identified critical limit has not been conducted to ensure that your process is controlling the pathogen growth and toxin formation hazards. Additionally, you have not had your finished product's water phase salt levels analyzed since November of 2009.
b. Your firm’s HACCP plan for RTE vacuum-packed cured Gravlax wild salmon lists a critical limit of "10% min. water loss" at the curing critical control point that is not adequate to control pathogen growth and toxin formation. A validation study that supports the adequacy of the identified critical limit has not been conducted to ensure that your process is controlling the pathogen growth and toxin formation hazards. Additionally, you have not had your finished product's water phase salt levels analyzed since November of 2009.
Your response to this violation is inadequate in that you have not provided documentation that a validation study has been performed.
We acknowledge you submitted revised HACCP plans as part of your firm’s response to the FDA-483. Upon further review of your HACCP plan associated with RTE cold smoked mussels, we observed that you did not identify Clostridium botulinum as a significant hazard associated with your manufacturing process. Please review the latest edition of the Fish and Fishery Products Hazards and Controls Guidance as well as your hazard analysis and HACCP plans to determine the appropriate identification of this hazard at specific processing steps within your processing operation.
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). Your firm’s HACCP plan for RTE vacuum-packed cold smoked mussels lists continuous temperature monitoring at your storage critical control point to control the pathogen hazard. You did not have a continuous temperature monitoring device in cooler #2 where RTE cold smoked mussels were being stored overnight on July 31, 2012 and August 1, 2012.
Your response provides confirmation that a 6-channel continuous temperature monitoring device was purchased and installed. You have not provided documentation to demonstrate that the device has been installed and is being used appropriately in cooler #2.
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 following areas of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. Exclusion of Pests – FDA observed four (4) bats perched between a screen and a window and feces on the floor of the attic where finished product packaging is stored. Spider webs, live and dead flies were present in the employee break room where finished product packaging, brown sugar and spices are stored. Flies were observed in the brining room, smoking room and packing room during processing and observed landing on cold smoked salmon in the process of being packaged.
b. Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces including utensils, gloves; and outer garments, and from raw product to cooked product - FDA observed an employee spraying a high pressure water hose to clean off sanitizer from the brining tank and spraying the tank in the direction of the three-bay sink where RTE mussels were in the process of being thawed. An employee was observed rinsing utensils and equipment with a pressurized hose in the first bay of your three-bay sink while mussels were being thawed and soaked in the second and third bays. Employees were observed not washing or sanitizing their hands or equipment prior to processing RTE cold smoked mussels. FDA also observed an open beverage can in the processing room.
c. Condition and cleanliness of food contact surfaces including utensils, gloves, and outer garment – FDA observed that the concentration of quaternary ammonium sanitizer being used to sanitize food contact surfaces after the completion of production was undetectable. Also, plastic mesh mats on which RTE mussels are brined were not cleaned and sanitized as food contact surfaces.
d. Proper labeling, storage, and use of toxic compounds – FDA Observed two unlabeled containers of blue liquid being stored in the brining room on July 30, 2012. Mr. Johnson later identified the liquid as quaternary ammonium.
e. Prevention of food, food packaging material and food contact surfaces from adulterants –Finished product packaging was being stored under your break room table with observed condensate dripping near the stored packaging materials. Lastly, a dusty vent was located above your three-bay sink where food contact surfaces are cleaned, washed and sanitized and where mussels are thawed.
f. Safety of the water that comes into contact with food or food contact surfaces – FDA observed that your exterior well cap was not locked on July 31, 2012. This well cap is the only barrier protecting your manufacturing facility's water supply.
The corrective actions described in your response appear adequate. FDA will verify these corrective actions during a reinspection of your facility.
4. 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 was not maintaining sanitation monitoring records that addressed the below five key areas of sanitation: (1) safety of water that comes into contact with food or food contact surfaces; (2) protection of food, food packaging material, and food contact surfaces from adulteration; (3) proper labeling, storage and use of toxic chemicals; (4) control of employee health conditions, and (5) exclusion of pests.
Your response to this violation is inadequate in that you did not provide documentation to support that the new sanitation monitor log is currently being used.
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 Fish and Fishery Products (seafood Hazard Analysis and Critical Control Point - HACCP) regulation, and the Current Good Manufacturing Practice regulation (21 CFR 123 & 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: Christopher M. Elliott, Acting 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. Elliott at 781-587-7428.
Mutahar S. Shamsi
New England District