FDA WARNING_LETTER - Kim Chemicals Private Ltd. - June 09, 2017

The FDA issued a Warning Letter to Kim Chemicals Private Ltd. following a June 5-9, 2017 inspection of their drug manufacturing facility in Maharashtra, India. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations, rendering their drug products adulterated.

Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a))**: Multiple batches of Sofskin Vaporizing Chest Rub and another product failed to meet specifications, including active ingredient content, yet were shipped to the U.S. The firm admitted to not routinely testing batches, instead reusing old test results. 2. **Inadequate Quality Control Unit (21 CFR 211.22(a) and (d))**: The firm lacked an adequate quality control unit and written procedures for critical operations like complaint handling, recalls, out-of-specification investigations, deviations, rejects, returns, and stability. 3. **Incomplete Laboratory Records (21 CFR 211.194(a))**: No records supported analytical testing results on certificates of analysis. The firm indicated destroying original test documentation after transcribing results.

The FDA also identified Sofskin Vaporizing Chest Rub and Sofskin Pure Petroleum Jelly as unapproved new drugs and misbranded drugs. Sofskin Vaporizing Chest Rub's formulation and labeling for nasal decongestant and cough suppressant indications did