# FDA 483 - Eagle Pharma Outsourcing LLC - August 12, 2021

Source: https://www.keypedia.com/records/483/eagle-pharma-outsourcing-llc/ea55a069-41be-4ad6-bde4-e376963a6991

> FDA 483 for Eagle Pharma Outsourcing LLC on August 12, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eagle Pharma Outsourcing LLC
- Inspection Date: 2021-08-12
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: The FDA Form 483 details deficiencies observed during an inspection of a facility involved in aseptic processing and drug product manufacturing.

**Facility and Operations:** The facility produces sterile drug products, including Triamcinolone, Betamethasone, Dexamethasone, and Methylprednisolone, in vial and suspension forms. Operations involve vial filling in ISO-5 classified areas and stability testing.

**Violations and Observations:**

1.  **Environmental Monitoring Deficiencies:**
    *   Surface sampling in the ISO-5 vial filling room is not conducted in the most critical areas (center of LAFW) where aseptic manipulations occur, but rather on outer areas.
    *   The particle counting probe for non-viable particles in the ISO-5 vial filling machine is positioned greater than (b)(4) from the most critical area, failing to obtain a meaningful sample.

2.  **Aseptic Processing and Sterilization Validation Deficiencies:**
    *   **Cleaning and Disinfection:** The system for cleaning and disinfecting aseptic processing areas to achieve aseptic conditions is deficient.
    *   **Smoke Study:** A June 2020 smoke study revealed turbulence within the ISO-5 classified area of the (b)(4) vial filling machine at critical production points during routine interventions.
    *   **Sterilization Validation:** The (b)(4) validation by a third-party contractor did not adequately specify a load pattern for Triamcinolone in (b

## 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 - 2025-02-27](https://www.keypedia.com/records/483/eagle-pharma-outsourcing-llc/de2ff863-9a0c-4758-b58c-151cdd892248)

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)
- [June P. Page](https://www.keypedia.com/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)
- [Investigator](https://www.keypedia.com/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

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

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea