Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District|
One Montvale Avenue
Stoneham, Massachusetts 02180
Phone: (781) 587-7500FAX: (781) 587-7556
CMS # 289057
March 22, 2012
Joseph H. Jolly III, CEO
Plenus Group Inc.
101 Phoenix Avenue
Lowell, MA 01852
Dear Mr. Jolly:
We inspected your seafood processing facility, located at 101 Phoenix Avenue, Lowell, Massachusetts on February 8 to March 2, 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 refrigerated clam chowder in reduced oxygen packaged bags is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 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 control 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 Ready-to-Eat Refrigerated Soups:
a. Fails to list a critical control point for the (b)(4) during the manufacturing process for controlling the food safety hazard(s) of Clostridium botulinum and toxin formation.
b. Fails to list a critical control point at Finished Product Storage to control Clostridium botulinum growth and toxin formation.
c. Fails to list a critical control point for metal detection to control metal fragments that may be introduced during the process.
d. Fails to list a critical control point for container sealing to control reintroduction of bacteria.
2. You must have a HACCP plan that 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 Ready-to-Eat Refrigerated Soups:
a. Lists a critical limit, “Product must be cooked to at least (b)(4)F” and “held at that temperature for at least (b)(4)” at the Cooking critical control point that is not adequate to control Clostridium botulinum and toxin formation.
b. Fails to list a critical limit at the “Chilling” critical control point to control the hazard of pathogenic bacteria. For example, your firm’s HACCP plan fails to list a critical limit for an adequate approved sanitizer concentration to prevent the introduction of pathogens via cooling water during the cooling process.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and frequency for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm’s HACCP plan for Ready-to-Eat Refrigerated Soups lists a monitoring frequency at the Allergen Control critical control point of (b)(4) that does not ensure the control of allergens.
We acknowledge receipt of your response dated March 16, 2012 and find it inadequate in that either your response did not include your corrective actions in a revised HACCP plan or your response did not address the FDA 483 item.
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. 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: Bruce R. Ota, Compliance Officer, at the above address. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-587-7487
Mutahar S. Shamsi
New England District