Inspections, Compliance, Enforcement, and Criminal Investigations
ConAgra Foods Inc 9/20/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
September 20, 2013
WARNING LETTER NO. 2013-NOL-20
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Ron Holbrook, Plant Manager
ConAgra Foods, Inc.
540 East Broadway
Newport, Tennessee 37821-3212
Dear Mr. Holbrook:
On May 6-10, 2013, United States Food and Drug Administration (FDA) investigators inspected your low-acid and canned food manufacturing facility, located at 540 East Broadway, Newport, Tennessee. This inspection found your firm manufactures a variety of low-acid and other canned foods including, but not limited to, Hunt’s pasta sauces and ketchup, Van Camp’s beans, Ranch Style beans, Manwich Sloppy Joe sauce, and Rosarita beans. The inspection determined you have significant deviations from the Low-Acid Canned Foods (LACF) regulations, Title 21, Code of Federal Regulations, Part 113 (21 CFR 113).
As a manufacturer of low-acid canned food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the federal regulations relating to the processing of low-acid canned food products. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed LACF Packaged in Hermetically Sealed Containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control [21 United States Code (USC) 344]. A temporary emergency permit may be required for low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR 113.
In addition, based upon certain criteria in 21 CFR 113, low-acid foods may be adulterated within the meaning of Section 402(a)(4), [21 USC 342(a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and the low-acid food regulations through links on FDA’s Internet home page at www.fda.gov.
We received your firm’s response to the Form FDA 483 (FDA 483) on May 22, 2013, and our evaluation of your response is discussed below. Violations revealed during the inspection include, but are not limited to, the following:
1. When containers were removed from the retort, following an emergency stop, the subsequent handling methods used for the containers in the retort at the time of the temperature drop were not entered on production records, as required by 21 CFR 113.40(c)(9).
Specifically, on February 20, 2013, a cooker was shut down around 02:44 due to an infeed jam. There is no documented evidence to show how many cans were affected or how the cans were handled. Additionally, during the thermal processing of Ranch Style Beans with Jalapenos on August 21, 2012, in the (b)(4), an unknown event(s) prompted cans to be discharged from the retorts. There is no documentation on the (b)(4) log sheet regarding the reason the cans were discharged and held. Associated (b)(4) log information is insufficient and also contains conflicting information.
We reviewed your response to the FDA 483 received on May 22, 2013. In your response, there is no documentation of how many cans of product were destroyed during production date of February 20, 2013. Your firm failed to ensure the cans just entering the retort, which could have been under-processed, were included in the product destroyed. You indicated that you will update your (b)(4) procedure to include the number of cans destroyed. We also request that you indicate the manner in which the cans are destroyed. Furthermore, you explained compliance with the new procedure will be verified daily during your (b)(4) review process in the quality department. Your response did not indicate what changes have been made in the quality department to ensure food is safely produced. Your response also states the reason for the cans being discharged from the retort on August 21, 2012, was noted on your plant records. You explain the “(b)(4)” shows that Ranch Style Beans with Jalapenos were diverted from (b)(4) equipment into the bright (b)(4) system and placed on hold due to possibly being over processed. Additionally, the “(b)(4)” indicated that “(b)(4)” was the reason the product was over processed. However, as our investigators informed you, the (b)(4) sheet did not indicate the reason the cans were discharged and held. There is contradictory information regarding the documentation of whether (b)(4) or (b)(4) pallets were held.
Furthermore, review of “(b)(4)” for production date of August 21, 2012, showed the reason for the hold is “(b)(4)” however, notation “(b)(4)” was written on the same record. We are concerned the form states “(b)(4)” which may indicate an under processed product. This statement indicated a potential food safety risk. Again, there is no documentation on how many cans were affected to affirm that under-processed cans were not released for distribution and the number destroyed.
2. Forms used to record processing or production information lack the code number and retort or processing system number, as required by 21 CFR 113.100(a). Specifically, recording charts for the (b)(4) did not always identify the retort and cooking shell. Recording charts associated with production of Ranch Style Beans on June 28 and August 21, 2012, did not identify with the retort or cooking shell. Additionally, (b)(4) control charts for Ranch Style Beans with Jalapenos manufactured on January 30, 2013, were lacking product codes, dates, identification of ingredient weighed, shift, and/or line number.
We reviewed your response to the FDA 483 received on May 22, 2013. Your response states the retorts are internally identified as (b)(4) and (b)(4). Each rotary has (b)(4) shells identified as (b)(4). The outside edge of the charts referenced above, near the time stamp, is “(b)(4)” or “(b)(4)”, which reportedly corresponds to the cooking shells and is understood by plant employees. However, the charts did not include the information needed to identify the rotary retort, as required by 21 CFR 113.100(a).
Your response to the observation regarding the weight control charts indicated Quality Assurance (QA) and operations personnel will be retrained to reinforce proper documentation procedures and compliance will be verified daily during your (b)(4) review process in the quality department. We will verify your corrective actions during our next inspection.
3. Records of all container closure examinations did not specify product code, as required by 21 CFR 113.100(e). Specifically, (b)(4) did not always include the product code. Out of 16 (b)(4), 13 did not include a product code, or contained an incorrect product code.
We reviewed your response to the FDA 483 received on May 22, 2013. Your response indicated the software used to, (b)(4) by your (b)(4), (b)(4) department has been upgraded and the upgraded software did not include the product code for Ranch Style Beans with Jalapenos. Your response stated your firm will manually record the product code until the software can be reprogrammed to include all product codes for each of your products processed. This response appears acceptable.
Next, your response confirmed the, (b)(4) records did not include the product code number; however, you explained this information can be identified by cross referencing the production schedule, accounting information, line number, code date, and can size. This practice is not in compliance with 21 CFR 113.100(e), which states, written records of all container closure examinations shall specify the product code, the date and time of container closure inspections, the measurements obtained, and all corrective actions taken. Records shall be signed or initialed by the container closure inspector and reviewed by management with sufficient frequency to ensure the containers are hermetically sealed.
Furthermore, the inspection conducted on May 6-10, 2013, revealed a practice of concern performed by your firm. The inspection revealed your firm sorted cans through a (b)(4) and threw out the cans which have become swollen or leaky. Reportedly, if cans passed the (b)(4) tests, after they have been held and multiple sorts have been performed, your firm released remaining cans for distribution. No additional microbiological testing was performed. Reportedly this is a standard practice for your firm. This practice does not adequately address the evaluation of cans which have been, or may have been compromised. Therefore, it is in violation of Section 402(a)(4), [21 USC 342(a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they have become contaminated with filth, or whereby they may have been rendered injurious to health.
This letter is not intended to be an all-inclusive list of deficiencies in your plant. It is your responsibility to ensure all of your products comply with the Act, the low-acid canned food regulations (21 CFR 108 and 113), and the Current Good Manufacturing Practice regulations (21 CFR 110), and other applicable regulations. The specific violations noted in this letter and in the FDA 483, issued at the close out of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your product into compliance.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.
You should respond in writing within fifteen (15) working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter please contact Ms. Dutzek at (615) 366-7826.
Patricia K. Schafer
New Orleans District
cc: Steve Townshend, Vice President, Manufacturing
ConAgra Foods, Inc. Corporate
One ConAgra Drive, 1-100
Omaha, Nebraska, 68102-5001
Chris Fosse, Vice President, Quality
ConAgra Foods, Inc. Corporate
One ConAgra Drive, 1-100
Omaha, Nebraska, 68102-5001