FDA 483 - Biocon Biologics Limited - May 01, 2018

The FDA Form 483 details several deficiencies at the facility. Disinfection efficacy studies for the Filling and Finish Area (BF/STY/001/P) did not demonstrate adequate control of microbial contamination or confirm residual disinfectant levels. A separate study (BF/CQC8/STY/P/313) used a spray application method for disinfectants on coupons, which differs from the mop and wipe application used in production areas, potentially impacting real-world efficacy.

Environmental monitoring is deficient, specifically lacking microbial monitoring for open operations during drug product formulation, preparation, compounding, and in LAF-026 (Grade C).

Cleaning procedures are inadequate. During manual glassware cleaning in the Grade D washroom F072, product contact surfaces were not fully exposed to cleaning agents, glassware was not filled as per SOP BF/FM/SOP/019 version 4, and glassware lids were not included in the cleaning procedure.

Inadequate behaviors to prevent raw material contamination were observed during dispensing. An operator cleaned the floor without changing or sanitizing gloves before resuming dispensing. Raw material containers were not sanitized before entering the dispensing hood. The same wipe was used to clean the balance and surrounding table. Raw material was stored in a battered cardboard box, and its transfer into a bin before entering the dispensing booth was noted, despite the material specification including endotoxin limits.

Operating procedures for dispensing were inconsistent. SOP CQC/M/SOP/