FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - September 27, 2024

This FDA Form 483 was issued to Biocon Sdn Bhd, a sterile drug product manufacturer in Iskandar Puteri, Johor, Malaysia, following an inspection from September 17-27, 2024. Dr. Rhonda Duffy, Ph.D., Executive Vice President and Chief Operations Officer, was the recipient.

The inspection revealed eight observations:

1. **Inadequate Procedures for Preventing Microbiological Contamination:** * **Poor Aseptic Behavior:** Operators were observed sanitizing hands before finger dabbing, blocking first pass air, using non-sterile tools, leaning on equipment, and improper glove sanitization. * **Intervention Documentation Issues:** Procedures for removing broken glass are not separate, conveyor belt shifts are not tracked, interventions are not fully documented in batch records, and interventions are categorized incorrectly. Specific interventions performed are not documented. * **Microbiological Monitoring Deficiencies:** Personnel exceeding recovery rates in Grade B area (QC Microbiology, Production Drug Product, QA, EM personnel) did not trigger investigations, contrary to procedures. * **Inadequate Visual Inspection Kits:** Challenge kits for visual inspectors do not adequately detect small glass particles, white/black particles, or fibers of known sizes. Verification of sample kits is not documented.

2. **Inadequate Validation of Aseptic Process:** * **Smoke Study Deficiencies:** Smoke studies on aseptic fill line did not meet acceptance