FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - February 15, 2018

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

**Key Violations and Observations:**

1. **Inadequate Microbiological Contamination Prevention:** * **Process Simulation Studies (Media Fills) Deficiencies:** * Rejected stoppered vials with seal defects (e.g., 846, 2,007, 1,310, 504, 139 units in various batches) were not incubated, contrary to control procedure BM/QA/SOP/019 Section 6.1.5, which states units with integrity defects should not be considered part of incubation. This practice is deemed insufficient, especially for multi-dose products. * Media fills for the REDACTED Filling Machine (03-02 REDACTED) do not accurately represent routine aseptic filling conditions. The frequency and duration of simulated operator interventions are not based on thorough historical or retrospective data evaluation.

2. **Inadequate Re-qualification of REDACTED Filling Machine (03-02 REDACTED):** * **REDACTED Re-qualification (Report BM/PDP/RQ/P/050-02, 02/04/2018):** Acceptance criteria for integrity, filling volume, and seal integrity were based only on "GOOD" units post-1