# FDA 483 - Biocon Biologics Limited - April 07, 2017

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/9003f4e1-97b6-4bc9-89a4-c3d018f10822

> FDA 483 for Biocon Biologics Limited on April 07, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biologics Limited
- Inspection Date: 2017-04-07
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection of Biocon Ltd., highlighting significant discrepancies and deficiencies in their manufacturing and quality control processes for drug substances and drug products.

**Key Observations:**

1.  **Documentation Discrepancies:** Inconsistencies exist between submitted information (b)(4) and actual manufacturing processes. Examples include differing in-process specifications, unlisted hold times for formulated bulk, and varying definitions for acceptance criteria versus action limits in batch manufacturing records (BMRs).

2.  **Inadequate Quality Assurance:** The Quality Assurance unit approved and implemented documents that do not ensure appropriate production, testing, deviation review, and release of commercial material.
    *   **Batch Release Issues:** Procedures allow release of drug substance batches with open deviations or Out-of-Specification (OOS) results, and drug product made from such drug substance, without proper conditional quarantine status.
    *   **Insufficient Data Review:** Procedures permit the analyst performing testing to also review data and release it to QA or make raw material usage decisions, lacking independent verification.

3.  **Inadequate In-Process Sample Handling:**
    *   Unprocessed bulk bioburden samples are settled for up to (b)(4) prior to testing, not mixed, and tested with (b)(4) above settled cells.
    *   No time limits exist between sampling in manufacturing and transfer to QC laboratories.

4.  **Lack of Quality Oversight

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## Related Officers

- [Lindsley Brown](https://www.keypedia.com/people/lindsley-brown/4dba0908-0029-4e6d-aeca-6e6ab5bdc047)
- [Maria Teresa Gutierrez-Lugo](https://www.keypedia.com/people/maria-teresa-gutierrez-lugo/6a539f71-91a7-4d23-9c97-e6d9730eaba5)
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- [Reyes Cendoya-Chacon](https://www.keypedia.com/people/reyes-cendoya-chacon/bd18f577-57fe-4183-9e04-28edfa7a3f95)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c