# FDA 483 - Biocon Biologics Limited - Unknown Date

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/1dff6c9a-dd43-4ecd-bfcd-53b9e68b1d05

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Biocon Limited, a drug product manufacturer in Bangalore, India, was cited for significant deficiencies in its aseptic processing and quality control systems. The inspection revealed inadequate procedures and practices to prevent microbiological contamination during sterile drug product filling operations, alongside a failure to conduct thorough investigations into environmental monitoring excursions with effective corrective actions. These issues indicate a lack of control over critical manufacturing processes and quality systems.

## Related Documents

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

## Related Officers

- [Diane Raccasi](https://www.keypedia.com/people/diane-raccasi/5c51bbf4-9c91-49c5-a1a5-d5aa7374890b)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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

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