FDA WARNING_LETTER - Alchymars ICM SM Private Limited - September 15, 2017

The FDA issued a Warning Letter to Alchymars ICM SM Private Limited following a September 11-15, 2017, inspection of their Tamil Nadu, India, drug manufacturing facility, identifying significant CGMP deviations for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Falsification of laboratory data:** Discrepancies in CFU counts for water point-of-use tests and observed growth on selective media despite reported absence, particularly concerning for API used in sterile injectable forms. 2. **Inadequate equipment maintenance:** Damaged product-contact surfaces (e.g., deteriorating gaskets) on multi-product equipment, with a lack of gasket replacement records, a repeat observation from a 2015 inspection. 3. **Insufficient quality unit investigations:** Failure to thoroughly investigate customer complaints regarding black spots and out-of-specification moisture content in API, without detailed record reviews. 4. **Poor facility maintenance:** Filthy equipment washroom with damaged tiles and standing water, and visibly dirty handwashing stations in cleanroom areas. 5. **Inadequate personnel facilities:** Inconveniently located and non-functional handwashing stations lacking hot water, soap, or hand drying equipment, also a repeat observation.

The FDA deemed the company's responses inadequate and strongly recommended engaging a qualified CGMP consultant to address systemic issues, particularly data integrity, laboratory controls, investigations, maintenance, and quality oversight