Inspections, Compliance, Enforcement, and Criminal Investigations

Hartford Provision Company Inc. d/b/a HPC Foodservice 8/14/15

  

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 # 475363
 
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
 
August 14, 2015
 
 
Mr. Barry L. Pearson, President and CEO
Hartford Provision Company
625 Nutmeg Rd. N.
PO Box 1228
South Windsor, CT 06074-2440 
                                                                                   
Dear Mr. Pearson:
 
We inspected your seafood processing facility, located at 625 Nutmeg Rd. N., South Windsor, CT on June 16-18, 2015, June 23, 2015, and June 25, 2015, and July 10, 2015. 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 (21 CFR 123). 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 ready-to-eat, canned pasteurized canned crab meat and seafood salad 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 and Controls Guidance, Fourth Edition, through links in FDA's home page at www.fda.gov.
 
Your significant violations were as follows:
 
1.    You must conduct or have conducted for you 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." However, your firm’s HACCP plan for pasteurized canned crab meat and refrigerated, ready-to-eat seafood salad does not list the food safety hazards of Clostridium botulinum growth and toxin formation or pathogenic bacteria growth and toxin formation.
 
We acknowledge your written response dated July 27, 2015 to the investigators observations, particularly that your firm is revising your HACCP plan to include hazards reasonably likely to occur such as pathogenic bacteria growth and toxin formation or Clostridium botulinum growth and toxin formation. This response is inadequate because it does not provide any timeframe for conduct of a hazard analysis and revision of your HACCP plan, or any documentation of a revised HACCP plan.  
 
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, list the critical controls 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 food process at which control can acceptable levels.”   However, your firm’s HACCP plan for pasteurized canned crab meat and refrigerated, ready-to-eat seafood salad does not list receiving as a critical control point for controlling the food safety hazards of pathogenic bacterial growth and toxin formation Clostridium botulinum growth and toxin formation.
 
For example, during our inspection, we noted your firm’s HACCP plan did not list receiving as a CCP to control Clostridium botulinum growth and toxin formation and pathogenic bacterial growth, and toxin formation hazards. Consequently, your firm did not implement receiving procedures that would ensure receipts were monitored at appropriate frequencies and that prompt corrective actions were taken following temperature discrepancies. For example:
  • Between March 31, 2015 and June 16, 2015 your firm received numerous shipments of seafood salad and did not monitor receiving temperatures until as long as 2.5 days after receipt of goods. 
  • On June 5, 2015 and June 12, 2015 your firm received shipments of seafood salad and did not monitor and record any receiving temperatures.
  • On 06/18/16, your firm received 16 cases of pasteurized crab meat at a temperature of 44.6oF and no corrective action was taken.
We acknowledge your written response dated July 27, 2015 to the investigators observations, particularly that your firm will revise your HACCP plan to include receipt of product. This response is inadequate because it does not provide any timeframe for conduct of a hazard analysis and revision of your HACCP plan, or any documentation of a revised HACCP plan. 
 
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, your firm’s HACCP plan for pasteurized canned crab meat lists a monitoring procedure and frequency at the “(b)(4)” critical control point for storage of product that is not adequate to control the food safety hazards of pathogenic bacterial growth and toxin formation or Clostridium botulinum growth and toxin formation.
 
For example, we found your HACCP plan critical control point “(b)(4) lists a monitoring step & frequency of “(b)(4)” with a frequency of “(b)(4)” in addition to “(b)(4)” which activate only when the cooler temperature exceeds (b)(4). Neither the method nor frequency of this monitoring is adequate to control the hazards and assure your firm meets your critical limit of “(b)(4)”.   FDA recommends that finished product is held at cooler temperatures of 40ºF (4.4ºC) or below. The temperature of cooler should be continuously monitored using a continuous temperature-recording device (e.g., a recording thermometer), with a visual check of the recorded data at least once per day.   
 
We also note your firm considers storage of product on refrigerated loading docks to fall under the “(b)(4)” CCP.   As stated above neither the method nor frequency in your HACCP plan for monitoring of this CCP at a refrigerated loading dock is adequate to control the hazards and assure your firm meets your critical limit of “(b)(4)”.
 
We acknowledge your written response dated July 27, 2015 to the investigators observations, particularly that your firm has purchased and installed a continuous monitoring system for the cooler and freezer. This response is inadequate. Your response does not address monitoring of other refrigerated locations used for storage such as the loading docks. Also your response lacked critical information including daily verifications checks, alarm set points, record keeping or a revised HACCP plan.
 
4.    You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control the food safety hazards of Clostridium botulinum growth and toxin formation and pathogenic bacterial growth and toxin formation when a deviation from your critical limit at the “(b)(4)” critical control point occured.
 
During our inspection, we found your firm failed to implement corrective actions when temperatures exceeded the critical limit of 40oF specified in your HACCP plan at “(b)(4)”. On April 14, 2015, the temperature on refrigerated loading docks 5 & 6 was recorded at 42oF. Seafood salad products were received and stored on the loading docks between April 14, 2015 and April 15, 2015. In addition, you did not have any temperature monitoring records prior to April 14, 2015.
 
We acknowledge your written response dated July 27, 2015 to the investigators observations, particularly that your firm will revise corrective action procedures. This response is inadequate because it does not provide any timeframe for revision or a revised corrective action plan.  
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.
 
Also, in accordance with 21 CFR 123.10, HACCP plan development, reassessment, modification and record review must be performed by an individual that has completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration, or who is otherwise qualified through job experience to perform these functions. Your firm does not have anyone trained in seafood HACCP or otherwise qualified through job experience to perform seafood HACCP functions. 
 
Also, in accordance with 21 CFR 123.6 (b)(2), firms may group kinds of fish and fishery products together if the food safety hazards, critical control points, critical limits, and procedures required to be identified are identical for all fish and fishery products so grouped. Your pasteurized canned crab meat has a potential food safety hazard of Clostridium botulinum growth and toxin formation and pathogenic bacteria growth and toxin formation, but your refrigerated ready-to-eat tuna salad has a potential food safety hazard of scombrotoxin (histamine) formation. These food safety hazards have different control strategies and thus require separate HACCP plans. You should conduct hazard analyses for each type of fish and fishery product and assure that where required and HACCP plan is developed and implemented specific to the hazard and control strategy. 
 
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 One Montvale Ave, Stoneham, MA 02180 Attention: Maya M. Davis, Compliance Officer. If you have questions regarding any issues in this letter, please contact Ms. Davis at 860-240-4289 ex. 25.
  
Sincerely,
/S/ 
Amber G. Wardwell
Acting District Director
New England District

Page Last Updated: 08/25/2015
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