FDA WARNING_LETTER - RIJ Pharmaceutical LLC - April 13, 2018

On March 28, 2019, the FDA issued a Warning Letter to RIJ Pharmaceutical LLC following an inspection from April 3-13, 2018, which revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211). The facility's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The water system consistently produced water exceeding microbiological limits, including potentially pathogenic bacteria, and lacked adequate ongoing microbial monitoring. Process validation studies for drug product mixing were not conducted, leading to super-potent batches requiring rework. 2. **Failure to establish adequate laboratory controls (21 CFR 211.160(b)):** Microbiological test methods were not adequately verified or validated to recover pathogenic microorganisms, and products were not tested for all USP-specified impurities. 3. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** Investigations into sennosides laxative syrup odor complaints were inadequate, failing to ensure product stability over shelf-life or recall affected lots. 4. **Failure of the quality control unit to