# FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/biocon-sdn-bhd-company-no-201101002193/8f6ffff4-f1cd-44cb-a9d3-817b2c96a316

> FDA 483 for Biocon Sdn. Bhd. (Company No. 201101002193) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Sdn. Bhd. (Company No. 201101002193)
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Biocon Sdn. Bhd. in Iskandar Puteri, Malaysia, was cited for significant deficiencies in its drug substance and drug product manufacturing facility. Observations included inadequate aseptic processing controls, unvalidated cleaning procedures for non-product contact equipment, and insufficient quality unit oversight. Additionally, the firm's deviation investigations were found to be inadequate, water and process (b)(4) systems were not assured for intended use, and batch record documentation practices were poor.

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd