| Public Health Service Food and Drug Administration |
Chicago District |
Department of Health and Human ServicesFebruary 4, 2011
WARNING LETTER
CHI-03-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Richard J. Czimer, Jr.
Owner
Czimer Foods, Inc.
13136 West 159th Street
Homer Glen, Illinois 60491
Dear Mr. Czimer:
The Food and Drug Administration (FDA) inspected your food processing facility, located at 13136 West 159th Street, Homer Glen, IL, on July 8, July 12, August 25, and September 16, 2010. We found that you have serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and associated regulations. You can find the Act and regulations on FDA’s website at www.fda.gov.
On July 12, 2010, during the inspection, FDA collected samples of a number of your products, including your Black Bear Burger and your Black Bear Steak products. These products are adulterated within the meaning of Section 402(b)(2) of the Act [21 U.S.C. § 342(b)(2)] in that a valuable constituent (Black Bear) has been omitted from the products and another ingredient has been substituted wholly therefore. Specifically, your Black Bear Burger product was found to contain Elk/Red Deer (Cervus sp.) rather than Black Bear (Ursus americanus), and your Black Bear Steak product was found to contain Brown Bear (Ursus arctos) rather than Black Bear.
Furthermore, your Black Bear Burger and Black Bear Steak products are misbranded within the meaning of Section 403(b) of the Act [21 U.S.C. § 343(b)] in that they are offered for sale under the name “Black Bear Burgers” and “Black Bear Steak” but are in fact Elk/Red Deer (Cervus sp.) and Brown Bear (Ursus arctos) , respectively.
During our inspection, we also found that you have serious violations of the Current Good Manufacturing Practice (CGMP) regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Because the food products produced in your facility have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health, these products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].
During the inspection, our investigators observed the following significant violations of 21 CFR 110:
1. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials did not conform to hygienic practices to the extent necessary to protect against contaminations of food, as required by 21 CFR 110.10(b), including maintaining adequate personal cleanliness [21 CFR 110.10(b)(2)] and washing hands thoroughly to protect against contamination [21 CFR 110.10(b)(3)]. Specifically, an employee removed Ready-To-Eat (RTE) cheese products with his bare hands, from your retail display case, without washing and sanitizing his hands prior to handling the RTE cheese and without wearing gloves. The employee then portioned the cheese products with bare hands for a consumer and placed the RTE cheese product back into the display case.
2. You did not manufacture, package, and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and the contamination of food, as required by 21 CFR 110.80(b)(2). Specifically,
• You do not have a set thermal process for the smoking of exotic meat slim jims and meat jerky products, and do not monitor the smoking operation for processing time or smoking temperature. Further, you do not calibrate the thermometers used in the facility. These conditions and controls are necessary to minimize the potential for growth of microorganisms during the smoking process.
• You do not monitor the pH or water activity of refrigerated, smoked vacuum packed exotic meat slim jims and meat jerky products. These properties can affect the time and temperature necessary to properly smoke the meat products, which would minimize the potential for growth of microorganisms during the smoking process.
3. Your facility failed to use cleaning compounds and sanitizing agents that are safe and adequate under the conditions of use, as required by 21 CFR 110.35(a). Specifically, your facility used a (b)(4) based sanitizer, but the sanitizer was not produced or maintained at the concentration specified on the label, which could render the sanitizer unsafe. An employee twice attempted to mix the sanitizer to the appropriate concentration, and on both attempts the (b)(4) concentration was significantly greater then the maximum strength specified on the label.
4. Your facility failed to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing as necessary, as required by 21 CFR 110.80(b)(1). Specifically, on a day that no meat was being cut, the band saw used to cut and section frozen meat pieces had dried particles of meat scraps on the blade, the handle, and in the grooves of the saw’s processing table.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the 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 corrections 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.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225 or rosemary.sexton@fda.hhs.gov.
Sincerely,
/s/
Scott J. MacIntire
District Director
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