Inspections, Compliance, Enforcement, and Criminal Investigations
Kohler Mix Specialties of Minnesota, LLC 02/04/2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142
February 4, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 10
Gregg L. Engles
Chairman of the Board and Chief Executive Officer
Dean Foods Company
2315 McKinney Avenue, Suite 1200
Dallas, Texas 75201
Dear Mr. Engles
On August 5,7-8, 11, 13-14 and September 2, 2008, we inspected your low-acid canned food manufacturing facility, Kohler Mix Specialties of Minnesota (a division of Dean Foods Company), located at 4041 Highway 61 North, White Bear Lake, Minnesota. We found that you have serious deviations from the Low-Acid Canned Food regulations (21 CFR Parts 108 and 113).
As a manufacturer of low-acid canned foods, 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 Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108), and Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (21 CFR 113). The Emergency Permit control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control [21 U.S.C. § 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 of 21 CFR 113. In addition, based upon certain criteria in 21 CFR 113, low-acid canned foods may be adulterated within the meaning of section 402(a)(3) of the Act (21 U.S.C. § 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or if they are otherwise unfit for food, or within the meaning of section 402(a)(4) [21 U.S.C. § 342(a)(4)] in that 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. Your firm's failure to fulfill the requirements of 21 CFR 108.35 and the mandatory requirements of 21 CFR 113 renders your Half & Half and 18% Light Cream products adulterated within the meaning of section 402(a)(4) of the Act. You can find the Act and the Low-Acid Canned Food regulations through links in FDA's home page at www.fda.gov.
We have reviewed the Kohler Mix Specialties response to the FDA 483 dated September 8, 2008, and have included our comments as appropriate in the numbered paragraphs below.
The significant violations were as follows:
1. Your firm failed to maintain records that document sterilization cycle times, as required by 21 CFR 113 .100(a)(4). Specifically, your Presterilization Checksheets for your Surge Tanks #6 and #7, your Filler Lines #6 and #7, and your Tank Supply Lines #6 and #7 for the (b)(4) filler line did not include a start time to ensure that the length of the sterilization cycle was sufficient.
Your September 8, 2008, response letter indicates that you have modified your records so that sterilization cycle start times will be documented. However, this response is inadequate because you have not provided evidence that you have trained your personnel to implement these corrections. We intend to assess implementation of the corrections described in your September 8, 2008, response concerning this violation during our next inspection.
2. 21 CFR 113.100(a) requires that your firm record critical factors specified in your scheduled process. However, your firm failed to document the following critical factors specified in our scheduled process: (a) (b)(4), (b) (b)(4) and (c) (b)(4).
Your September 8, 2008, response letter indicates that you have modified your records so that these critical factors will be documented. However, this response is inadequate because you have not provided evidence that you have trained your personnel to implement these corrections. We intend to assess implementation of the corrections described in your September 8, 2008, response concerning this violation during our next inspection.
3. For an intentional change in a previously filed scheduled process, your firm has failed to submit to CFSAN, within 30 days after first use, a complete description of the modifications made and utilized and a copy of the file record showing prior substantiation by a qualified scientific authority as to the safety of the changed process, in accordance with the requirements of 21 CFR 108.35(c)(21(ii). The (b)(4) Field Service Report, dated 10/19/07, for the (b)(4) indicated that the (b)(4) and that, based on this modification, there was no guarantee that the (b)(4).
Your firm's September 8, 2008, response states that you have requested and received a validation letter substantiating the safety of the modification of the (b)(4) (b)(4). However, this response is inadequate because FDA has not received this validation letter.
In addition to the above violations, we also have the following comment:
• Review of the charts for the (b)(4) processor, which are used to continuously monitor the critical factor of product outlet temperature, revealed that these charts read more than 1°F higher than the indicating thermometer (b)(4) on several occasions. The indicating thermometer must always read equivalent to or higher than the recording chart thermometer [21 CFR 113.40(g)(1)(i)(b)]. You should ensure that the corrective actions you described during the inspection and in your September 8, 2008, response letter are implemented daily and as appropriate to ensure that this requirement is met.
We request that you notify this office in writing within 15 working days of receipt of this letter stating the actions you will take to correct the violations discussed above and to prevent their recurrence. Include documentation that illustrates these corrections, if applicable. If corrective action cannot be completed within 15 working days, state the reason for the delay and a reasonable time within which the corrections will be completed.
Failure to make prompt corrections may result in enforcement action, including seizure, injunction, and emergency permit actions being initiated by the Food and Drug Administration (FDA). This letter does not represent a comprehensive review of all of the products distributed by your firm. As president, it is your responsibility to ensure that all products distributed by your firm are in compliance with the Act and its implementing regulations
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated in the letterhead. Ms. Wisecup may be reached at (612) 758-7114.
W. Charles Becoat
cc: Gregg A. Tanner
Executive Vice President and Supply Chain Officer
Dean Foods Company
2315 McKinney Avenue, Suite 1200
Dallas, Texas 75201