Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District Office|
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 412465
U.S. Postal Service
October 01, 2013
Mr. Julian Stogniew
Poultry Products Company, Inc., dba Poultry Products Northeast
11 Bemis Rd
Hooksett, NH 03106-2622
Dear Mr. Stogniew:
We inspected your seafood processing facility, located at 11 Bemis Rd, Hooksett, NH 03106-2622 on August 20 through August 27, 2013. 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, pasteurized, canned crab meat and salted, smoked herring 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.
Specific violations observed during the inspection include, but are not limited to, the following:
1. Your firm must have and implement a HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur as required by 21 CFR 123.6(b). However, your firm does not have a HACCP plan for refrigerated, pasteurized, canned crab meat to adequately control the food safety hazard of Clostridium botulinum.
We have received your firm’s response to the FDA 483, Inspectional Observations, via facscimile dated September 18, 2013. The response does not include a copy of a new HACCP plan for this product.
2. Your firm must conduct a hazard analysis for each kind of fish and fishery product that you produce 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 food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.”
Your firm did not conduct a hazard analysis regarding the food safety hazards associated with refrigerated, pasteurized, canned crab meat
Also, although your firm’s hazard analysis for salted, smoked herring includes histamine as a food safety hazard and a critical control point, the HACCP plan your firm utilizes for salted, smoked herring does not list histamines as a food safety hazard which requires a critical control point.
In addition, your firm is utilizing one HACCP plan, entitled “(b)(4),” for all fish and fishery products received by your firm. A hazard analysis is to be performed for each kind of fish and fishery product to determine if a HACCP plan with appropriate critical controls points is needed to control applicable food safety hazards for each of your firm’s fish and fishery products.
We have received your firm’s response to the FDA 483, Inspectional Observations,. Your response to the FDA 483 observation does not include a copy of a revised HACCP plan for this product or additional products.
3. Your firm must have a HACCP plan that lists the critical control points for each of the identified food safety hazards, to comply with 21 CFR 123.6(c)(2). A critical limit 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 entitled, “(b)(4),” does not list the (b)(4) utilized by your firm as a critical control point for salted, smoked herring to control histamine.
Your FDA 483 response to the observation does not include a copy of a revised HACCP plan for this product.
4. You must have a HACCP plan that, at a minimum, lists the critical limit 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, entitled, “Fresh Seafood,” lists a critical limit of "40 deg. Or below at receiving for each product received" at the receiving critical control point. This critical limit does not ensure the food safety hazards related to the receipt of refrigerated, pasteurized, canned crab meat and salted, smoked herring were controlled adequately throughout transit.
Your firm’s response does not include a copy of a revised HACCP plan for these products for the agency to review.
5. Your firm 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, your firm’s HACCP plan, entitled “(b)(4),” lists a critical limit of “(b)(4)”. This critical limit does not ensure the monitoring of the temperatures of received products, including refrigerated, pasteurized, canned crab meat and salted, smoked herring, are being controlled adequately throughout transit.
6. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). The corrective action listed in your HACCP plan, entitled “(b)(4),” states if a product exceeds (b)(4), this product may be placed in a freezer until the product’s temperature reaches (b)(4). This corrective action is not adequate to control food safety hazards, including Clostridium botulinum in refrigerated, pasteurized, canned crab meat and scobrotoxin formation (histamine) in salted, smoked herring. In addition, your corrective action does not include investigating the root cause of the deviation from the critical limit.
7. As your firm performs repacking of fish and fishery products, your firm 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). Under 21 CFR 123.11(c), you are required to maintain, at a minimum, sanitation records that document the monitoring of the following conditions and corrections: 1) the safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; 2) condition and cleanliness of food contact surfaces; 3) prevention of cross-contamination from insanitary objects to food; 4) maintenance of hand washing, hand sanitizing, and toilet facilities; 5) protection of food, food packaging material, and food contact surfaces from adulteration from chemical, physical, and biological contaminants; 6) proper labeling, storage, and use of toxic compounds; 7) control of employee health conditions; and 8) exclusion of pests. The sanitation control records maintained by your firm do not monitor these conditions and practices.
In addition, your firm’s plant construction and design shall be constructed in such a manner that floors may be adequately cleaned, kept clean, and kept in good repair as required by 21 CFR 110.20(b)(4). Your firm’s floors in areas of food storage were observed to be cracked, damaged, and uneven.
Your September 18, 2013 response does not include a copy of the documentation related to this FDA 483 observation.We suggest that you use the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition to evaluate your firm’s operation regarding seafood products. While the guidance is not a binding set of requirements it does provide information that will most likely result in a HACCP plan that is acceptable to FDA. Firms may choose other control measures, but they are then responsible for scientifically establishing their adequacy. 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: Todd Maushart, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Maushart at 781-587-7578.
Joseph Matrisciano Jr.
Acting District Director
New England District Office