FDA WARNING_LETTER - Pure Source LLC - March 01, 2018

On February 20, 2019, the FDA issued a Warning Letter to Pure Source LLC following an inspection from February 8 to March 1, 2018. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR, parts 210 and 211), rendering their drug products adulterated. The firm also manufactures and distributes misbranded homeopathic drugs.

Key violations include: 1. **Failure to investigate discrepancies (21 CFR 211.192):** Pure Source LLC failed to thoroughly investigate out-of-specification (OOS) results, including a raw material lot with excessive microbial growth (too-numerous-to-count for total aerobic microbial count, exceeding the specification of less than (b)(4) CFU/g) used in an OTC acne treatment. They distributed finished product made with this contaminated material and did not identify microorganisms or assess consumer hazard. OOS assay results for other drug products were also released without thorough investigation. 2. **Inadequate test method validation (21 CFR 211.165(e)):** The firm failed to adequately validate test methods used with their (b)(4) microanalyzer for microbiological testing of deionized water, raw materials, and finished products. 3. **Failure to establish adequate production and process control procedures (21 CFR 211.