FDA WARNING_LETTER - Czimer's Foods, Inc - September 16, 2010

The FDA inspected Czimer Foods, Inc. in Homer Glen, IL, on multiple dates in 2010, revealing serious violations of the Federal Food, Drug, and Cosmetic Act. Samples of "Black Bear Burger" and "Black Bear Steak" were found to be adulterated under Section 402(b)(2) of the Act, as Black Bear was substituted with Elk/Red Deer and Brown Bear, respectively. These products were also misbranded under Section 403(b) due to inaccurate labeling. Furthermore, the facility exhibited serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110), rendering products adulterated under Section 402(a)(4) due to insanitary conditions. Specific CGMP deficiencies included employees not conforming to hygienic practices, such as handling Ready-To-Eat cheese with bare hands. The firm failed to manufacture, package, and store foods under conditions to minimize microbial growth, lacking a set thermal process, monitoring, and calibration for smoked exotic meats, and not monitoring pH or water activity. Additionally, cleaning compounds and sanitizing agents were not used safely and adequately, with sanitizer concentrations significantly exceeding label specifications. Equipment and utensils, such as a band saw, were not maintained in an acceptable condition, showing dried meat scraps. Czimer Foods, Inc. must investigate and correct these violations promptly, providing a written response within fifteen working days detailing corrective actions, prevention plans, and a timetable for completion, to avoid potential legal actions like seizure and injunction.