FDA 483 - Biocon Biologics Limited - August 19, 2022

The FDA Form 483 details six observations from an inspection.

**Observation 1** notes the failure to establish and follow adequate procedures to prevent microbiological contamination of sterile drug products.

**Observation 2** highlights inadequate facilities for preventing contamination, specifically citing a persistent trend of fungal contamination in the Site (b)(4) Drug Substance Block manufacturing facility from April 27, 2022, to June 21, 2022, with ongoing investigations into additional fungal recoveries. The firm has not thoroughly assessed the scope or potential entry routes of the contamination.

**Observation 3** indicates that written records of investigations into unexplained discrepancies and out-of-specification (OOS) results lack conclusions and follow-up. Investigations, such as OOS No. MM-OOS/A/20/009 (11/30/2020) for an IEX-HPLC result on (b)(4) bulk product, are not always scientifically sound or comprehensive, and resulting Corrective Action/Preventive Actions (CAPAs) do not always address root causes.

**Observation 4** states that cleaning and sanitation procedures for classified DS and DP manufacturing areas do not require documentation and verification of surface wetting for the stated contact time.

**Observation 5** points out that the disinfectant efficacy study (BFIQCQSISP/R/313) does not adequately support sanitization procedures for all representative