# FDA 483 - Biocon Biologics Limited - June 03, 2017

Source: https://www.keypedia.com/records/483/biocon-biologics-limited/d469f0a6-221d-4b96-a912-d98125df7f1b

> FDA 483 for Biocon Biologics Limited on June 03, 2017. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocon Biologics Limited
- Inspection Date: 2017-06-03
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA Form 483 inspection revealed numerous deficiencies at the facility, impacting sterile drug product manufacturing and quality control.

**Facility and Operations:** The facility manufactures sterile injectable drug products, including "Injection, mg/ml," which has observed visible particulates since August 2015 and is still sold in Uruguay, Russia, and the Dominican Republic.

**Violations and Observations:**

*   **Investigations:** Inadequate investigations into unexplained discrepancies and visible particulates, failing to extend to other batches or products.
*   **Risk Assessments:** No risk assessments performed after critical SOP updates (Microbiological Monitoring, Aseptic Process Simulation, Data Handling Systems Management) to assess impact on marketed products.
*   **Sterilization & Aseptic Processing:**
    *   Inadequate validation of sterilization processes.
    *   Lack of tracking for aseptic personnel and qualification requirements during media fills.
    *   Media fill activities and filling times are not tracked comprehensively.
    *   Sterile glove test not validated.
    *   HVAC validation and requalification procedures do not account for microbial levels.
    *   Deficient environmental monitoring systems and unspecified monitoring locations.
    *   Aseptic operators held to Grade B qualifications despite working in Grade A areas.
    *   Personnel monitoring held to Grade B specifications, except for Grade A glove testing.
    *   Procedures to prevent microbiological contamination are not established, written, or followed.

## 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

- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

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