FDA WARNING_LETTER - Balchem Corporation - June 10, 2009

This FDA Warning Letter, dated [Date not provided in excerpt], addresses significant Current Good Manufacturing Practice (CGMP) violations observed during an inspection of Balchem Corporation's pharmaceutical manufacturing facility in Channahon, IL, from May 20 to June 10, 2009. The violations render the firm's granulated calcium carbonate, an in-process material for drug products (antacids, postmenopausal medication) and a dietary supplement ingredient, adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Adulterated Drugs:** * Failure to reject in-process materials (e.g., Modified Calcium 58B Lot E8143A) despite microbial contamination (e.g., (b)(4) of (b)(4)). * Release of 94 lots of Modified Calcium 58B and Calcium Carbonate 1551-95 (P) despite coliform bacteria in water systems used for manufacturing, indicating unsanitary conditions. The firm's response regarding microbial identification and testing plans was deemed inadequate. 2. **Inadequate Laboratory Controls:** * Failure to establish scientifically sound specifications and test procedures. The firm engaged in "testing into compliance" by retesting contaminated samples (e.g., Modified Calcium 58B Lots E8064A and E8064B) and