Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm389817.htm
Timestamp: 2017-09-25 04:32:56
Document Index: 131280791

Matched Legal Cases: ['art 123', 'art 110', 'art 123', '§ 342', '§ 379', '§ 379']

E. W. Mailhot Sausage Company 3/17/14
CMS #421897
Mr. Roger Mailhot
258 Bartlett Street
Dear Mr. Mailhot,
We inspected your seafood processing facility, located at 258 Bartlett Street, Lewiston, ME on January 30, February 7, and 11, 2014. 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 offish 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 cooked, ready-to-eat salmon pies 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 Fishery Products Hazards and Controls Guidance, Fourth Edition, through links in FDA's home page at www.fda.gov.
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, your firm's HACCP plan for cooked, ready-to-eat salmon pies lists a critical limit, "Internal temperature of pie of (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.
It is our expectation that once you have validated your process and have established a new critical limit you will reassess the monitoring, recordkeeping, verification, and corrective action procedures listed in your HACCP plans at the cooking critical control point. 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 conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which controls can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for cooked, ready-to-eat salmon pies does not list the critical control point of in-process refrigerated cooler storage to control the food safety hazard of pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.
We acknowledge that your firm's HACCP plan for cooked, ready-to-eat salmon pies lists a critical control point at the cooler storage step. However, the critical limit at this critical control point states that it does "not apply to the pie cooling cooler unless products other than pies in the process of cooling are present".
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). However:
A. Your firm's HACCP plan for cooked; ready-to-eat salmon pies lists a monitoring procedure/frequency of taking the internal product temperature of only (b)(4) pie per oven load on an (b)(4) basis at the cooling critical control point that is not adequate to control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.
It is our expectation that once you have validated your process and have established new monitoring procedures you will implement those procedures. Your firm was observed to not follow the monitoring procedure of taking internal product temperatures on an (b)(4) basis at the cooling 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 cooked, ready-to-eat salmon pies. 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.
B. Your firm's HACCP plan for cooked, ready-to-eat salmon pies lists a monitoring procedure/frequency of taking the cooler temperature (b)(4) daily at the cooler storage critical control point that is not adequate to control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse.
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. Are-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 there-inspection and assessing and collecting there-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.
Mr. Marc R. Mailhot
E. W. Mailhot Sausage Company - Close Out Letter 11/17/14