FDA 483 - Biocon Biologics Limited - February 15, 2019

This FDA Form 483 documents observations from an inspection of a drug product fill line on February 8, 11, and 14, 2019, citing a failure to establish, write, adequately validate, and/or follow procedures to prevent microbiological contamination of sterile drug products, specifically regarding aseptic techniques in Grade A/B areas.

Key observations include: * **Lack of RABS inspection:** Operators did not inspect RABS after installation, pre-use, or post-use, contrary to SOP BF/FM/SOP/182 and SOP BF/FM/SOP/180. * **Inadequate RABS sanitization:** An operator failed to sanitize the RABS after an open operation in the Grade C area, violating SOP BF/FM/SOP/180 and SOP BF/FM/SOP/194. * **Deficient aseptic behavior procedures:** SOP BF/FM/SOP/180 is inadequate, lacking instructions to prevent contamination during transfer of large equipment from lower LAF shelves, as observed with an employee squatting. Operators also used knee-height tables in Grade B areas. * **Inadequate environmental sampling procedures:** SOP BF/QC/SOP/148 is insufficient, with no environmental testing at the location where dosing vessels are placed into RABS or during open aseptic connections. * **Inadequate aseptic process