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
November 19, 2013
RETURN RECEIPT REQUESTED
Robert R. Walters, President
Sanitary Dairy Foods, Inc.
2757 Magnolia Ave.
Saint Louis, MO 63118-1426
Dear Mr. Walters:
The U.S. Food and Drug Administration (FDA) conducted an inspection at your cheese manufacturing facility, Sanitary Dairy Foods, Inc., 2757 Magnolia Ave., Saint Louis, MO 63118-1426, between August 27 and 29, 2013. As a manufacturer of human 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 human food products. During our inspection, our investigator documented significant deviations of the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulations, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). The inspection revealed your cheese products are adulterated within the meaning of Section 402(a)(4) of the Act [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. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.
The following deviations, observed and documented by our investigators during the inspection and through analysis of samples collected, cause your cheese products, manufactured, processed, packed, or held at your facility, to be adulterated:
1. You failed to conduct manufacturing, including packaging and storage, under such conditions and controls necessary to minimize the potential for the growth of microorganisms, or for the contamination of food, as required by 21 CFR 110.80(b)(2). Specifically, during the inspection, environmental samples were collected from various locations within your firm's processing facility. The analysis of these environmental samples found generic, non-toxigenic Escherichia coli (E. coli) in eleven subsamples collected from separate processing locations, including your mixing room and packaging room. The finding of E. coli in multiple processing locations within your facility is evidence of insanitary conditions.
FDA previously collected a finished product sample of your baker's cheese on July 23, 2013. FDA laboratory analysis found generic,non-toxigenic E. coli at> 1,100 most probable number (MPN) per gram in the composite tested. The presence of excessive levels of non-toxigenic E. coli in your baker's cheese caused the finished product to be adulterated within the meaning of section 402(a)(4) in that your products have been prepared, packed, or held under insanitary conditions whereby products may have become contaminated with filth.
2. You failed to take necessary precautions to protect against contamination of food contact surfaces with microorganisms and foreign substances, as required by 21 CFR 110.10(b)(9). Specifically, our investigators observed an employee who was packaging your baker's cheese would insert his gloved hand (and arm) inside the plastic product bag to open the bag and then place the bag in a plastic bucket before filling the bag with product. He would then use his gloved hands to operate equipment and perform other duties before opening another bag for filing. At no time during the production run (b)(4) did the employee wash and sanitize his hands or replace gloves before touching the inside of the plastic product bags.
The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. As a manufacturer of food products, you are responsible for assuring that your overall operation and the products you manufacture and distribute are in compliance with the law. It is your responsibility to assure adherence with each requirement of the Act and the implementing regulations. You should take immediate steps to attain compliance with the law. This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies.
You should know that these serious violations of the law might result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizure, and/or injunction.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. Are-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-inspectionrelated costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of there-inspection and assessing and collecting thereinspection 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.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If conective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
Your response should be sent to Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Dr., Lenexa, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer, Jessica E. Hensley at 913-495-5183.
Acting District Director
Kansas City District Office