# FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - February 15, 2018

Source: https://www.keypedia.com/records/483/biocon-sdn-bhd-company-no-201101002193/df3b519f-0669-48ed-a8cd-bc3c435a6309

> FDA 483 for Biocon Sdn. Bhd. (Company No. 201101002193) on February 15, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Sdn. Bhd. (Company No. 201101002193)
- Inspection Date: 2018-02-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection of a facility manufacturing sterile drug products.

**Key Violations and Observations:**

1.  **Inadequate Microbiological Contamination Prevention:**
    *   **Process Simulation Studies (Media Fills) Deficiencies:**
        *   Rejected stoppered vials with seal defects (e.g., 846, 2,007, 1,310, 504, 139 units in various batches) were not incubated, contrary to control procedure BM/QA/SOP/019 Section 6.1.5, which states units with integrity defects should not be considered part of incubation. This practice is deemed insufficient, especially for multi-dose products.
        *   Media fills for the REDACTED Filling Machine (03-02 REDACTED) do not accurately represent routine aseptic filling conditions. The frequency and duration of simulated operator interventions are not based on thorough historical or retrospective data evaluation.

2.  **Inadequate Re-qualification of REDACTED Filling Machine (03-02 REDACTED):**
    *   **REDACTED Re-qualification (Report BM/PDP/RQ/P/050-02, 02/04/2018):** Acceptance criteria for integrity, filling volume, and seal integrity were based only on "GOOD" units post-1

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## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
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Company: https://www.keypedia.com/companies/biocon-sdn-bhd-company-no-201101002193/b7eb03f4-676c-44c0-af88-528fbc4236a8

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