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

Source: https://www.globalkeysolutions.net/records/483/biocon-sdn-bhd-company-no-201101002193/b42334d3-b594-4d06-bd84-44dbdf7434f5

> FDA 483 for Biocon Sdn. Bhd. (Company No. 201101002193) on September 27, 2024. 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: 2024-09-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Biocon Sdn Bhd in Iskandar Puteri, Johor, Malaysia, revealed critical deficiencies in aseptic processing, quality control, and investigation practices. The firm exhibited poor aseptic techniques, inadequate validation of sterile manufacturing processes, and failed to accurately document microbiological results and manage corrective actions effectively. These findings indicate a lack of robust controls necessary to ensure the sterility and quality of drug products.

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## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.globalkeysolutions.net/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8