Biocon Sdn. Bhd. (Company No. 201101002193) – FDA 483, Feb 21, 2020
Biocon Sdn Bhd in Iskandar Puteri, Malaysia, received a Form 483 with three observations highlighting significant deficiencies in quality control and manufacturing processes for sterile drug products. The firm failed to thoroughly investigate unexplained discrepancies in batch records related to environmental monitoring interventions and lacked adequate procedures to prevent microbiological contamination. Additionally, the quality control unit demonstrated failures in its responsibilities, including missing equipment qualifications and prematurely closing a CAPA.
- Inspection date
- February 21, 2020
- Product type
- biologics
ID · a0f8c894-0375-4456-8e4a-381835759c81
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