Inspections, Compliance, Enforcement, and Criminal Investigations
Maine Harvest Seafood 11/19/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
November 12, 2009
WARNING LETTER NYK 2010-06
Via Federal Express
Thomas Landry, President
TMC Food, LLC.
d.b.a. Maine-Harvest Seafood
650 Pennsylvania Ave.
Elmira, NY 14904
Dear Mr. Landry,
We inspected your seafood processing facility, located at 650 Pennsylvania Ave., Elmira, NY 14904 on July 1, 8, and 10, 2009. 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 pasteurized canned crab meat, farm raised tiger shrimp, wild caught shrimp, bluefish, mackerel, mahi, ahi tuna, tuna, shad roe, and escolar 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 conduct a hazard analysis to determine whether there are food safety hazards that are reasonably' "likely to occur and you must have a HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for wild shrimp or aquacultured shrimp to control the food safety hazards of sulfite additives in wild caught shrimp, or chemicals and drugs in aquacultured shrimp.
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, your firm did not
follow the monitoring procedures of visually checking for the presence of ice or record the
cooler temperature for your pasteurized canned crabmeat product at the receipt or storage
critical control points to control Clostridium botulinum toxin formation hazard listed in your
HACCP plan for pasteurized canned crab meat. Specifically, on July 1, 2009, the FDA
Investigator observed· that your firm receives canned crabmeat and that there was no ice
present on the cans at receipt, and that no ice was added at the storage step. Furthermore,
your firm did not record the temperature of the truck-trailer which delivered the canned
crabmeat or the storage cooler at the time the product was put in the cooler.
3) You must implement the record keeping system that you listed in your HACCP plan to comply with 21 CFR 123.6(b). However, according to your "Daily HACCP Report" and
invoices, your firm did not record monitoring observations required by your plan including cooler temperature or the presence of ice at the receiving; critical control point to control the histamine (for the histamine forming group) or Clostridium botulinum (for the pasteurized canned crabmeat) hazard identified in your HACCP plan for the following products: pasteurized canned crabmeat, bluefish, mackerel, tuna, mahi, shad roe, escolar and ahi tuna.
4) To comply with 21 CFR 123.6(c)(4), you must have a HACCP plan that, at minimum, lists appropriate monitoring procedures for each critical control point. However, your firm's HACCP plan for the histamine fish group, the non-botulinum group, and the botulinum group lists monitoring frequencies at the storage critical control points that are not adequate to control histamine formation, pathogen growth, and Clostridium botulinum, respectively. Specifically, your monitoring frequency of (b)(4) for the storage critical control points for these product groups is not appropriate to determine that the critical limit is being met when your firm is not in operation.
FDA recommends the use of a continuous monitoring device such as a continuous temperature data logger for monitoring refrigerated cooler storage. In addition, we
recommend a daily check of the recorded temperatures to ensure that proper temperatures have been maintained, and a daily check of the monitoring equipment itself to ensure that it is operating properly. Alternatively, you may choose to perform a daily visual check of the adequacy of ice or cooling media surrounding product during refrigerated storage; however, your HACCP plan and monitoring records should reflect this monitoring activity accordingly. FDA recommends that you check the adequacy of ice or cooling media at least twice per day.
1) Your firm failed to properly store equipment, remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of your plant facility, per 21 CFR 110.20(a)(1). Specifically, the following was observed by our investigators:
• Apparent animal feces with multiple flying insects was observed on an outside walkway in the close proximity of the cooler; and a screen door that leads directly into the firm had multiple torn areas.
• Shellfish shells with exposed flesh that had attracted flying insects were observed under and around your firm's cooler.
• Your dumpster was observed to be open with waste material overflowing out of it which had attracted many flying insects and was in close proximity to the cooler and a screen door (with multiple tears) that leads directly into the firm.
2) You must provide your plant or facility, where necessary, adequate screening or other
protection against pests, to comply with 21 CFR 110.20(b)(7). However, you did not
provide adequate screening or other protection against pests as evidenced by the following
• Your back door and kitchen window, both of which lead directly into the processing area, had tears or holes in the screening.
3) You must ensure that equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process; rework, or food are constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination, to comply with 21 CFR 110.80(b)(7). However, your firm failed to handle and maintain containers and equipment that hold or convey food in a manner that protects against contamination, as evidenced by the following observations:
• Food products were stored directly below dripping condensation from the cooling unit in your walk-in cooler;
• Your can opener used to open canned food products contained food residues and rust;
• Your ice scoop was lying directly on top of the uncleaned ice machine and under a soiled air fan.
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
Please send your reply to the Food and Drug Administration, Attention: Dean Rugnetta, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo, NY 14202. If you have questions regarding any issues in this letter, please contact Mr. Rugnetta at 716-541-0324.
Laurence D. Daurio
Acting District Director
New York District
Cc: Michael J. Ferraro, Manager
Maine Harvest Seafood
650 Pennsylvania Ave.
Elmira, NY 14904