FDA 483 - Dr. Reddy's Laboratories Ltd. - August 20, 2019

The FDA Form 483 details multiple deficiencies at a pharmaceutical manufacturing facility. The quality control unit lacks authority for full error investigations. Sterilization processes for sterile drug products lack adequate validation, with inconsistencies noted in load configurations between initial validation (05/05/2016) and re-qualification (27/03/2019) for a REDACTED process. There are no diagrams or photographs to compare load configurations. Biological indicator (BI) challenge locations for sterilization cycles may not represent worst-case scenarios, and potential uncontacted areas exist. Manual cleaning of a Continuous Particle Monitoring System is not supported by data comparable to a validated process.

Deviations from production procedures are not justified. Aseptic processing areas have deficient air supply and pressure control. Non-Viable Particle (NVP) monitoring is inadequate; there's no NVP monitoring between the REDACTED and REDACTED during aseptic filling, nor during vial transfer to the REDACTED, failing to substantiate Grade A environment maintenance. NVP monitoring frequency in a Grade D manufacturing room lacks scientific rationale, and sampling locations do not cover personnel manual activities. Airflow patterns in cleanrooms show turbulence, impacting the evaluation of interventions. Environmental monitoring system (EMS) alarm delays are not realistic.

Microbiological testing of components and drug product containers is insufficient. An analyst's settle plate evaluation missed microorganisms, and the firm does not characterize microbial contaminants if their morphology is similar