# FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - February 21, 2020

Source: https://www.globalkeysolutions.net/records/483/biocon-sdn-bhd-company-no-201101002193/a0f8c894-0375-4456-8e4a-381835759c81

> FDA 483 for Biocon Sdn. Bhd. (Company No. 201101002193) on February 21, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Sdn. Bhd. (Company No. 201101002193)
- Inspection Date: 2020-02-21
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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## Related Officers

- [Vidya B. Pai](https://www.globalkeysolutions.net/people/vidya-b-pai/bbe3989c-b7b0-40a0-ae0b-a35c81cdd179)
- [Development Coordinator](https://www.globalkeysolutions.net/people/shawn-e-larson/a3515e47-60a3-48ff-b27c-f79bd03db12b)

Company: https://www.globalkeysolutions.net/companies/biocon-sdn-bhd-company-no-201101002193/b7eb03f4-676c-44c0-af88-528fbc4236a8

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1