Apitoria Pharma Private Limited – FDA 483, Aug 2, 2022

This FDA Form 483 details observations from an inspection, highlighting deficiencies in equipment cleaning, investigation of discrepancies, and quality control unit procedures.

**Observation 1** notes inadequate cleaning and maintenance procedures for equipment. Specifically, re-cleaning operations for two pieces of equipment ([redacted] and [redacted]) were initiated but not completed for approximately 21 and 22 days, respectively. Visible white powder and brown rust were observed on a [redacted] feeding line port, despite a logged cleaning completion on June 22, 2022, with a swab yielding [redacted] ppm of [redacted]. Visible white powder residue was also found inside a [redacted] used for manufacturing.

**Observation 2** identifies a failure to thoroughly investigate unexplained discrepancies. Between July 1 and August 1, 2022, 6337 error messages were logged for HPLC and GC equipment used for release and stability testing, including "Instrument Failure" (411), "Sequence stopped because of error" and "sequence stopped by user" (13), and "Failed to get the newest information of the batch queue because of the communication failure" (20). No holistic investigation or corrective actions were performed. Additionally, a market complaint regarding black particles in a finished tablet product did not include evaluation of retention samples.

**Observation 3** indicates that quality control unit responsibilities and procedures are not fully followed. Devi