# FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - July 20, 2023

Source: https://www.globalkeysolutions.net/records/483/biocon-sdn-bhd-company-no-201101002193/a1b1d4cf-8a75-42f3-b146-485dbfc22819

> FDA 483 for Biocon Sdn. Bhd. (Company No. 201101002193) on July 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Sdn. Bhd. (Company No. 201101002193)
- Inspection Date: 2023-07-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Biocon Sdn Bhd, a drug manufacturer in Iskandar Puteri, Malaysia, was cited for significant deficiencies in its aseptic processing, quality control, and quality system. Repeat observations included failures in preventing microbiological contamination, inadequate investigations into batch failures and OOS results, and insufficient procedures for maintaining aseptic conditions. The inspection also highlighted issues with method validation, employee training, risk analysis for device components, and CAPA documentation, indicating a broad lack of control over critical manufacturing and quality processes.

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## Related Officers

- [Rong Guo](https://www.globalkeysolutions.net/people/rong-guo/13e19eca-0154-45e1-8ab3-ee45d31c4d05)
- [Cso](https://www.globalkeysolutions.net/people/daniel-j-lahar/d4e329c0-b6a5-42ca-acde-b79413b245ea)
- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Eileen A. Liu](https://www.globalkeysolutions.net/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

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