# Biocon Biologics Limited – FDA 483

Source: https://www.keypedia.com/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

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- [483 - 2024-07-26](https://www.keypedia.com/records/483/biocon-biologics-limited/edb15a2b-be4c-4cce-a170-6454059f2901) — date: July 26, 2024
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- [483 - 2022-08-19](https://www.keypedia.com/records/483/biocon-biologics-limited/152eb2db-adeb-44c2-883a-bdac69a6cc99) — date: August 19, 2022
- [483 - 2019-09-19](https://www.keypedia.com/records/483/biocon-biologics-limited/81b17a36-3d2a-4a82-a70c-77f6fce4507a) — date: September 19, 2019

## Related Officers

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

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

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