# FDA 483 - Catalent Belgium SA - August 19, 2022

Source: https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/a5641d00-652f-47a6-a7f2-a1b291a6e2c8

> FDA 483 for Catalent Belgium SA on August 19, 2022. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Belgium SA
- Inspection Date: 2022-08-19
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 details multiple deficiencies observed during an inspection of a facility manufacturing drug products for the US commercial market, including a combination drug/device.

Key observations include:
- **Aseptic Processing Areas:** Air visualization studies in RABs failed to demonstrate sufficient airflow velocity over critical areas of filling machines, particularly during interventions.
- **Deviation Investigations:** The firm failed to thoroughly review unexplained discrepancies and perform proper root cause analysis for sterilizing equipment issues, despite recurring observations of sterilized part contamination between 2019 and 2021.
- **Process Control:** Aseptic filling process simulations (media fills) performed after significant HVAC changes were deficient, failing to consider major changes to HEPA filters and not simulating worst-case conditions (larger openings, low filling speed).
- **Equipment Qualification:**
    - Sterilization cycle requalification used incorrect part types.
    - Integrity tester performance qualification studies were deficient, with incorrect study parameters and potential for false negatives.
    - Integrity test results were recorded as Pass/Fail without numerical values or initial/final pressure records.
    - Equipment clean hold time studies were deficient, not demonstrating cleanliness after a single cleaning cycle.
    - Climate-controlled chamber qualifications (stability chambers, refrigerators, incubators) were deficient, lacking recorded temperature/humidity recovery times.
- **Data Integrity:**
    - QC instruments and equipment lacked protection from manipulation; procedures allowed analysts to change date and

## Related Documents

- [483 - 2017-07-07](https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/53e42813-d6b8-477e-883e-6b1c94f2e69f)
- [483 - 2017-07-07](https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/7ec032fb-d69c-40c5-b216-56d25037461d)
- [EIR - 2022-08-19](https://www.globalkeysolutions.net/records/eir/catalent-belgium-sa/885f1132-6075-4922-909a-a5d88ab0e69d)
- [483 - 2026-02-07](https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/fa83cb21-e34f-4eac-9039-a029ee5ef976)
- [483 - 2021-10-26](https://www.globalkeysolutions.net/records/483/catalent-belgium-sa/93f734e2-857b-42f7-a28d-23a89c5695ba)

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.globalkeysolutions.net/companies/catalent-belgium-sa/f48653bf-84a2-4aeb-bdc3-ca2d0cc4fdf2

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe