• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

E. W. Mailhot Sausage Company 3/17/14

  

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 #421897

UNITED PARCEL SERVICE
OVERNIGHT DELIVERY

March 17, 2014
 

Mr. Roger Mailhot
President
E. W. Mailhot Sausage Company
258 Bartlett Street
Lewiston, ME 04240

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.

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, 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.

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 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. 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.
 

Sincerely,
/S/

Mutahar S. Shamsi
District Director
New England District
 

Cc:
Mr. Marc R. Mailhot
Vice President
E. W. Mailhot Sausage Company
258 Bartlett Street
Lewiston, ME 04240