Inspections, Compliance, Enforcement, and Criminal Investigations
Crowley Foods Arkport, Division of HP Hood, LLC 10/5/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
October 5, 2009
WARNING LETTER NYK-2010-01
VIA FEDERAL EXPRESS
Rick Kovarich, Division Director
Division of HP Hood LLC
Crowley Foods Arkport
233 Main Street
Agawam, MA 01001-1851
Dear Mr. Kovarich:
We inspected your seafood processing facility, located at 25 Hurlbut Street, Arkport, NY 14807 on May 18, 19, 22 and 26, 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 (b)(4) Sour Cream Dip New England Clam is adulterated, in that it has been prepared, packaged, 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 Part 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 Sour Cream Clam Dip does not list the critical control point of refrigerated storage for controlling the food safety hazard of pathogen growth and toxin formation. The FDA recommends continuous monitoring of cooler temperatures with a data logger, and visual check of the temperature record, and the instrument itself at least once per day.
2) 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 Part 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 Sour Cream Clam Dip lists a critical limit "pH (b)(4) maximum At (b)(4) hours post packaging At temperature of less than or equal to (b)(4)F" at the post packaging critical control point that is not adequate to control pathogen growth and toxin formation. For control of pathogens including Clostridium botulinum and Listeria monocytogenes, FDA recommends that the pH critical limit be reduced to below 4.4 if you chose to store product at (b)(4)F, or conversely, if the pH critical limit remains (b)(4) the temperature critical limit should be reduced, to 40F. Once you have established an appropriate critical limit, you must implement the monitoring and record keeping system listed in your HACCP plan.
3) You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for (b)(4) Sour Cream Dip New England Clam lists procedures for monitoring pH, but does not list time and temperature monitoring procedures to assure that your time and temperature critical limits are met at the post packaging critical control point to control pathogen growth.
4) You must take corrective actions when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take an appropriate corrective action to control the pathogen growth hazard when the critical limit for pH listed in your HACCP plan for (b)(4) Sour Cream Dip New England Clam was exceeded at the post packaging critical control point to control pathogen growth. For example, your monitoring records show that the pH for the following lots were above the critical limit listed in your HACCP plan and no corrective action was taken; these lots were still shipped into commerce: (b)(4)
5) Because you chose to include corrective actions in your HACCP plan dated May 26, 2009, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your firm's corrective action plan states that when a pH deviation occurs, you will verify procedures and retrain employees and reject the product. Your plan does not describe the disposition of the rejected product (e.g. destroy the lot, rework the lot, etc.) which is essential to assuring that potentially unsafe product does not enter commerce.
6) You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c). However, during the current inspection of your firm on May 18, 19, 22 and 26, 2009 You did not maintain any sanitation monitoring records for eight areas of sanitation for the (b)(4) Sour Cream Dip New England Clam. On May 19, 2009, your firm provided a written sanitation program which was provided to the FDA. However, your firm must maintain records to show that your firm is performing these procedures when your firm manufactures seafood products.
The eight areas of sanitation are as follows:
• Safety of water
• Condition and cleanliness of food contact surfaces
• Prevention of cross-contamination from insanitary objects
• Maintenance of hand-washing,. hand sanitizing; and toilet facilities
• Protection of food, food packaging material, and food contact surfaces from adulteration
• Proper labeling, storage, and use of toxic chemicals
• Control of employee health conditions
• Exclusion of pests
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.
We acknowledge your response email from Mr. Wright on June 8, 2009 to the FDA 483 Inspectional Observations, this response is inadequate to correct the violations as described above. Please send your reply to the Food and Drug Administration, Attention: Dean Rugnetta, Compliance Officer, 300 Pearl Street, Buffalo, NY 14202. If you have questions regarding any issues in this letter, please contact Mr. Rugnetta at 716-541-0324.
Camille D. Monde
New York District