Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
April 7, 2014
Mr. Gary Rodkin, Chief Executive Officer
ConAgra Foods, Inc.
One ConAgra Drive
Omaha, NE 68102
Dear Mr. Rodkin,
On January 8-10, 13-16, 21, and 27, 2014 U.S. Food and Drug Administration (FDA) investigators inspected your sunflower seed manufacturing plant, located at 8064 Chivvis Drive, Afton, MO 63123. The inspection was conducted to determine your compliance with FDA's Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). During the inspection, insanitary conditions were documented, which could cause the food products manufactured by your facility to become adulterated. Accordingly, your food products are adulterated within the meaning of Section 402(a)(4) of the Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342 (a)(4)] as they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You may find the Act and associated regulations through links in FDA's Internet home page at http://www.fda.gov.
During the inspection, FDA investigators observed the following significant CGMP violations:
1. You have failed to demonstrate the procedure used for cleaning and sanitizing of equipment is effective, as required by 21 CFR 110.35(d)(5)
On 1/14/14 your firm was advised environmental sampling for Listeria would be performed in your production areas. Your firm performed a (b)(4) cleaning and sanitation of all equipment on 1/14/14. On 1/15/14 investigators took environmental swabs from numerous production areas in your facility. A total of four swabs were positive for Listeria including three swabs from your panning area, located after the roasting step, that were positive for Listeria welshimeri (L. welshimen) and one swab that was positive for Listeria innocua (L.innocua). These findings from areas in close proximity to food contact surfaces are indicative of insanitary conditions in your facility, and highlight the need for more effective cleaning and sanitation operations.
2. Your firm failed to take reasonable precautions to ensure that production procedures do not contribute to contamination from any source, as required by 21 CFR 110.80.
On 1/15/2014 our investigators observed employees leave the production areas to go to the break room, locker rooms, walk outside and return to work without donning proper production attire. These employees were handling, operating and brushing against other equipment throughout the panning area. The repeated touching of production surfaces and wearing street clothing which contact production surfaces is a potential source of product contamination during the preparation and production of Ranch Flavored Sunflower seeds, lot #21764015BBN.
On 1/18/14 our investigators observed the cleaning of panning equipment using caustic foam cleaner, (b)(4) to clean food contact surfaces of equipment in the panning room. During the inspection it was observed employees did not verify the proper strength of the cleaner as required per your firm's standard operating procedure (SOP).
3. Your firm failed to maintain gloves, if they are used in food handling, in an intact, clean, and sanitary condition, as required by 21 CFR 110.10(b)(5).
For example, on 1/18/14 our investigators observed (b)(4) employees cleaning and handling spilled product in the filler and touching inside of trash containers. The employees resumed packaging finished product without washing hands and replacing their gloves; your firm was manufacturing dill flavored sunflower seeds, lot#21764008XXN.
Also on 1/15/14 when your firm was manufacturing Ranch Flavored sunflower seeds, lot# 21764015BBN, our investigator observed the panning operator touching controls and work surfaces with gloved hands and would then mix product with the same gloved hands without changing
This letter is not intended to include a comprehensive list of deficiencies at your facility. It is your responsibility to ensure your facility operates in full compliance with the Act and all applicable federal regulations.
You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to correct these violations may result in regulatory action without further notice, including seizure or injunction.
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as photographs, records, and other useful information, to assist us in evaluating your corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
As noted above, on 1/15/2014, FDA collected one environmental sample consisting of 39 swabs that were collected from various food contact and non-food contact surfaces in your firm's roasting/brining room and also in the panning room. Three swabs collected in the panning room, were positive for non-pathogenic L.innocuaand one swab was positive for L.wefshimeri. Another swab, collected under a leaking drain pipe in the roasting room where employees walk through into the panning room, was also positive for L.we/shimeri. We note that these Listeria findings are indicative of insanitary conditions in your processing facility that require your prompt attention. We acknowledge your letter dated January 13, 2014, concerning the Listeria findings in your plant, and your reference to modifying facility food safety plans by February 28, 2014, based on scientific studies on your sunflower seed roasting process for destroying vegetative pathogens. We request that your response to FDA also include the study details and data obtained from this study to determine the effectiveness and validation of your roaster kill step.
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover 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 there-inspection fees [21 USC 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.
Your response should be sent to U.S. Food and Drug Administration, Danial Hutchison, Compliance Officer at the address noted above. If you have any questions with regard to this letter, CO Hutchison can be reached at (913) 495-5154 or email Daniai.Hutchison@fda.hhs.gov
David L. Miser
Acting District Director
Kansas City District