# FDA 483 - Catalent Indiana, LLC - May 12, 2023

Source: https://www.globalkeysolutions.net/records/483/catalent-indiana-llc/829baa07-8455-499c-9dad-a0f8cc30bae3

> FDA 483 for Catalent Indiana, LLC on May 12, 2023. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Indiana, LLC
- Inspection Date: 2023-05-12
- Office Name: Division of Biotechnology Manufacturing
- Summary: This FDA Form 483 details observations from an inspection, citing deficiencies in production and process controls, equipment maintenance, and quality system documentation.

**Violations and Observations:**

*   **Aseptic Technique Non-Adherence:**
    *   Failure to sanitize gloved hands during Flexible Fill Line stopper bowl setup.
    *   Incorrect transfer of stopper bowl from Grade C to Grade A space (bag not removed in Grade C).
    *   Complete removal of stopper bowl covering in Grade A, with a fill technician's exposed face over the uncovered bowl.
    *   Use of an unsterilized tool (forceps) for stopper jam dislodgement, expelling air onto a sanitized surface, violating aseptic intervention procedures.
    *   Failure to visually inspect gloved hands for multiple interventions on the Vial Filling Line.
*   **Equipment Sterilization and Integrity:**
    *   Sterilization of equipment within an isolator for docking to the Flexible Fill Line, where the isolator's integrity is not tested post-manufacture.
    *   Risk assessment (RA-21-05-001) fails to evaluate isolator integrity testing.
    *   Integrity of the (b)(4) for the Flexible Fill Line (b)(4) (sterile) (b)(4), conducted on a (b)(4) basis, is not considered in batch release. Corrective action for this deficiency is

## Related Documents

- [483 - 2022-09-01](https://www.globalkeysolutions.net/records/483/catalent-indiana-llc/d93759b0-6517-4cd1-8722-bb2bfdf4f02b)
- [483 - 2023-11-15](https://www.globalkeysolutions.net/records/483/catalent-indiana-llc/a1e8a879-3457-4a45-af4a-6ce304aa7c9e)
- [EIR - 2018-01-19](https://www.globalkeysolutions.net/records/eir/catalent-indiana-llc/9f95a6cc-aa76-4e85-9e7d-168b6c74315c)
- [EIR - 2017-05-19](https://www.globalkeysolutions.net/records/eir/catalent-indiana-llc/0b121283-25f2-4271-ad8f-7c96adb7a8ff)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/catalent-indiana-llc/70255023-0dba-4473-a659-64d38a7df3ea)

## Related Officers

- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [Hyung-yul Lee](https://www.globalkeysolutions.net/people/hyung-yul-lee/a790a804-2e43-4901-8d7d-0c656c464f0f)
- [company_representative](https://www.globalkeysolutions.net/people/steven-c-miltenberger-ii/a6586529-8ebb-424b-b6a9-caa7e46faf9c)

Company: https://www.globalkeysolutions.net/companies/catalent-indiana-llc/3422c8c4-978a-45ba-962b-b00002fffd6d

Office: https://www.globalkeysolutions.net/offices/division-of-biotechnology-manufacturing/3e3018f1-aa48-4010-a554-96f557f17c55