# FDA 483 - Biocon Biologics Limited - February 15, 2019

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/3858f9b9-9837-4adb-9001-eeb4c7a62761

> FDA 483 for Biocon Biologics Limited on February 15, 2019. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biologics Limited
- Inspection Date: 2019-02-15
- Office Name: Office of Pharmaceutical Quality
- Summary: This FDA Form 483 documents observations from an inspection of a drug product fill line on February 8, 11, and 14, 2019, citing a failure to establish, write, adequately validate, and/or follow procedures to prevent microbiological contamination of sterile drug products, specifically regarding aseptic techniques in Grade A/B areas.

Key observations include:
*   **Lack of RABS inspection:** Operators did not inspect RABS after installation, pre-use, or post-use, contrary to SOP BF/FM/SOP/182 and SOP BF/FM/SOP/180.
*   **Inadequate RABS sanitization:** An operator failed to sanitize the RABS after an open operation in the Grade C area, violating SOP BF/FM/SOP/180 and SOP BF/FM/SOP/194.
*   **Deficient aseptic behavior procedures:** SOP BF/FM/SOP/180 is inadequate, lacking instructions to prevent contamination during transfer of large equipment from lower LAF shelves, as observed with an employee squatting. Operators also used knee-height tables in Grade B areas.
*   **Inadequate environmental sampling procedures:** SOP BF/QC/SOP/148 is insufficient, with no environmental testing at the location where dosing vessels are placed into RABS or during open aseptic connections.
*   **Inadequate aseptic process

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## 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/office-of-pharmaceutical-quality/c3303908-9657-4cd3-ae43-2458c98e8a64