# FDA 483 - Eagle Pharma Outsourcing LLC - February 27, 2025

Source: https://www.keypedia.com/records/483/eagle-pharma-outsourcing-llc/de2ff863-9a0c-4758-b58c-151cdd892248

> FDA 483 for Eagle Pharma Outsourcing LLC on February 27, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eagle Pharma Outsourcing LLC
- Inspection Date: 2025-02-27
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 document details observations from an inspection of Eagle Pharma Outsourcing LLC, an outsourcing facility located at 2200 Riverchase Ctr Ste 675, Hoover, AL, conducted from February 18-27, 2025. The report was issued to Haleigh J. Wilkes, Quality Manager/Pharmacist in Charge (PIC).

The inspection revealed five observations related to quality system and manufacturing issues:

1.  **Lack of procedures to prevent microbiological contamination:**
    *   No smoke study was conducted for the ISO 5 Filling Cleanroom design.
    *   Turbulent eddy currents were observed during vial filling, and rubber stoppers were refilled in the presence of open vials without a protective barrier, posing a contamination risk. This is a repeat observation.
    *   The environmental monitoring program's sampling map failed to include contact surfaces within the pass-through used for component transfer between cleanrooms. This is a repeat observation.

2.  **Improper protective apparel use:** An environmental sampling technician exhibited poor sterile re-gowning techniques by leaning against a wall, rendering the gown non-sterile prior to entering the ISO 5 Filling room.

3.  **Inadequate equipment and utensil sanitization:** An environmental sampling technician failed to disinfect a stainless steel pan containing EM sampling plates and a particle counter before transferring them between cleanrooms. This is a repeat observation.

4.

## Related Documents

- [483 - 2018-05-18](https://www.keypedia.com/records/483/eagle-pharma-outsourcing-llc/f8fa994a-ba90-4b8b-b0bd-6b7a766a5db0)
- [483 - 2021-08-12](https://www.keypedia.com/records/483/eagle-pharma-outsourcing-llc/ae5e6e51-8247-4c90-81cd-9861a4336232)
- [483 - 2021-08-12](https://www.keypedia.com/records/483/eagle-pharma-outsourcing-llc/ea55a069-41be-4ad6-bde4-e376963a6991)

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Company: https://www.keypedia.com/companies/eagle-pharma-outsourcing-llc/6edf52f8-9dfe-4bca-b1d1-4f6da167361f

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9