FDA 483 - Indoco Remedies Limited - July 26, 2024

This FDA Form 483 details observations from an inspection of a drug product manufacturing facility.

**Observation 1** highlights deficiencies in handling consumer complaints. The firm failed to thoroughly investigate complaints, specifically PR# 166586 regarding missing labels on (b)(4) Solution vials. An internal evaluation revealed that vials with missing labels could bypass the rejection sensor under specific conditions (close proximity of bottles, or machine stoppage with a bottle under the sensor). An impact assessment of retain samples for missing labels showed inconsistent employee handwriting in raw data for several products. Additionally, multiple complaints from US consumers indicated container closure integrity and/or loss of sterility, including missing vials or no drug in the bottle.

**Observation 2** notes approximately 10 complaints about drug not dispensing from vials, with no corrective action initiated by the firm. It also cites inadequate validation of the aseptic process. Smoke studies had obstructed views of critical operations due to excessive smoke and did not assess airflow around sensors in the Grade A RABS filling area. Personnel monitoring samples for mask, forehead, and chest of employees working in Grade A RABS were held to less stringent Grade B specifications, rather than Grade A (no growth).

**Observation 3** identifies that responsibilities and procedures of the quality control unit are not in writing or fully followed. The QC unit failed to routinely review warning and error messages in the Empower message center, including "Injection----cannot be altered," "User Abort," "