FDA WARNING_LETTER - Keshava Organics Pvt. Ltd. - May 31, 2017

On March 15, 2018, the FDA issued a Warning Letter to Keshava Organics Pvt. Ltd. following an inspection from May 25-31, 2017, at their facility in Thane, Maharashtra, India. The letter cited significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations included: 1. **Inadequate Investigation of Out-of-Specification (OOS) Results:** The company failed to adequately investigate OOS results, often invalidating original failing results based on retests without proper Phase 1 laboratory investigations. They also lacked Phase 2 investigations to identify manufacturing root causes. A retrospective review revealed recurring OOS results with insufficient investigations and a lack of corrective and preventive actions (CAPA). The company also improperly categorized numerous OOS results as "incidents," avoiding substantive investigation.

2. **Failure to Maintain Complete Laboratory Control Records:** The facility failed to maintain complete data for API tested and distributed to the U.S., including missing sample weights, batch/lot numbers for reference standards, equipment identification, and complete thin layer chromatography data.

These deficiencies were repeat observations from previous FDA inspections in 2011 and 2014, indicating inadequate oversight. The FDA strongly recommended engaging a qualified CGMP consultant to remediate operations, including investigations, laboratory controls, data management, and quality unit authorities.