# FDA 483 - Biocon Biologics Limited - July 26, 2024

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/05a654d1-f83f-49b1-80a9-56f70dca615f

> FDA 483 for Biocon Biologics Limited on July 26, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biologics Limited
- Inspection Date: 2024-07-26
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details ten observations from an inspection.

**Observation 1:** Procedures for preventing microbiological contamination of sterile drug products lacked adequate aseptic process validation. Airflow visualization studies for the US market filling line showed turbulence and upward flow, failing acceptance criteria and protocol. Gaps between HEPA filters and RABS barriers were noted, with insufficient evaluation in studies. Interventions for vial and stopper removal did not consistently demonstrate good aseptic technique, and smoke studies for personnel/equipment crossing Grade A areas were not provided.

**Observation 2:** Procedures designed to prevent microbiological contamination were not followed. Operators extended sterile stoppers over closures during interventions. Aseptic behavior procedures were not adhered to on the vial filling line, with numerous unrecorded personnel and cart crossings of the Grade A laminar flow area, which are not considered interventions in aseptic process simulations.

**Observation 3:** Laboratory test procedures and controls were not established or followed. Analysts did not follow procedures for chromatogram integration, potentially leading to OOS results being reprocessed without proper documentation. Inconsistent selection of post-peaks for system suitability evaluation in RP-HPLC testing for purity and impurity determination resulted in potentially invalid assay results.

**Observation 4:** Computerized systems lacked controls and review of electronic data. Non-viable particle count data failing acceptance criteria were not reported in paper records, and source electronic data was not reviewed. Data older than April 25, 2024, was overwritten due to

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## Related Officers

- [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)
- [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)

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