# FDA 483 - Biocon Biologics Limited - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/biocon-biologics-limited/34a3f80d-5688-4e63-9006-3751d02f3b25

> FDA 483 for Biocon Biologics Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biologics Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Biocon Biologics Limited revealed significant deficiencies across its aseptic manufacturing operations, laboratory controls, and data management systems. Issues included inadequate validation of aseptic processes, failure to follow sterile procedures, compromised data integrity, and insufficient investigations into discrepancies. These findings indicate a high risk to the quality and sterility of drug products.

## Related Documents

- [483 - 2019-09-19](https://www.globalkeysolutions.net/records/483/biocon-biologics-limited/81b17a36-3d2a-4a82-a70c-77f6fce4507a)
- [483 - 2019-02-15](https://www.globalkeysolutions.net/records/483/biocon-biologics-limited/3858f9b9-9837-4adb-9001-eeb4c7a62761)
- [483 - 2018-05-01](https://www.globalkeysolutions.net/records/483/biocon-biologics-limited/6fa7e974-b5c4-450b-bb8f-8eb76ae4b514)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/biocon-biologics-limited/fdee272a-ef56-45fc-8061-233169edfabf)
- [483 - 2022-08-19](https://www.globalkeysolutions.net/records/483/biocon-biologics-limited/152eb2db-adeb-44c2-883a-bdac69a6cc99)

## Related Officers

- [Teresa I. Navas](https://www.globalkeysolutions.net/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)
- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Xiaoshi Wang](https://www.globalkeysolutions.net/people/xiaoshi-wang/8249ff14-dec6-4ffd-9893-bdf8ba6af7ce)
- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.globalkeysolutions.net/companies/biocon-biologics-limited/7eb84509-8dc4-4765-9a0e-d2f65781328d

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