Inspections, Compliance, Enforcement, and Criminal Investigations
ConAgra Frozen Foods, Inc. 14-Sep-05
Department of Health and Human Services
Public Health Service
September, 14, 2005
RETURN RECEIPT REQUESTED
Bruce C. Rohde, Chairman and CEO
ConAgra Frozen Foods, Inc.
One ConAgra Drive,
Omaha, NE 68102-5001
Dear Mr. Tracy:
Investigators from the U.S. Food and .Drug Administration conducted an inspection of your seafood processing facility, located at 3001 East Main Street, Highway 64 East, Russellville, Arkansas 72801 from July 12 through 14, 2005. We found you have serious deviations from Good Manufacturing Practice (GMP) regulations for Seafood HACCP [Title 21, Code of Federal Regulations (CFR), Part 123]. These deviations cause your seafood products to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Accordingly; your seafood products are adulterated, because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and Seafood HACCP Regulations through links in the FDA's home page at http://www.fda.gov.
The deviations were as follows:
You must conduct, or have conducted for you, 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(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."
Your firm's HACCP plan for the manufacture of shrimp egg rolls does not list a critical control point to control the food safety hazard of pathogen growth and toxin formation during production.
Your firm's HACCP plan for the manufacture of shrimp egg rolls does not list a critical control point to address the physical hazard of metal fragments.
Your firm's HACCP plan for the manufacture of frozen dinners containing tuna does not list a critical control point to address the chemical hazard of Scrombrotoxin (histamine) formation.
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 the manufacture of shrimp egg rolls lists a critical limit for cooling from a temperature of 120°F to 55°F in less than or equal to 6 hours. This critical limit is not adequate to control pathogen growth and toxin formation.
The above observations are not intended to be an all-inclusive list of violations. It is your responsibility to ensure adherence with all requirements of the Act and implementing regulations. You should take prompt action to correct these deviations and prevent any future recurrence. Failure to make prompt corrections could result in regulatory action without further notice. Possible actions include seizure, injunction and/or prosecution.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. Please also provide evidence, including revised procedures, revised forms, and a sample of records which display your corrections have been fully implemented. If corrective actions can not be completed within 15 working days, state the reason for delay and the time within which corrections will be completed.
Your response should be sent to Sherrie L. Kroiczyk, Compliance Officer at the above letterhead address. If you have questions regarding any issue in this letter, please contact Ms. Krolczyk, at 214/253-5312.
Michael A. Chappe
Dallas District Director