# Eagle Pharma Outsourcing LLC – FDA 483, Aug 21, 2015

Source: https://www.keypedia.com/records/483/eagle-pharma-outsourcing-llc/c4314e33-d966-4775-9524-a1c0ef100ac7

> FDA 483 for Eagle Pharma Outsourcing LLC on August 21, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eagle Pharma Outsourcing LLC
- Inspection Date: 2015-08-21
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: This FDA Form 483 details numerous deficiencies observed during an inspection of an outsourcing facility.

**Key Violations and Observations:**

*   **Quality System Failures:**
    *   Failure to thoroughly review batch failures: Two injectable drug products were released and distributed despite failing potency tests.
    *   Lack of established, written, and followed procedures to prevent microbiological contamination of sterile drug products.
    *   Inadequate validation for sterilization processes: A specific sterilization process for injectable drug suspensions was not supported by validation data for a particular product (methylprednisolone).
    *   Lack of calibration documentation for equipment (REDACTED used for REDACTED).
    *   No stability data to support the 180-day expiration date assigned to all injectable drug products.
    *   Laboratory controls lack scientifically sound and appropriate test procedures; injectable drug products are not tested using validated methods.

*   **Aseptic Processing and Environmental Control Deficiencies:**
    *   **Contamination Risks:**
        *   Bulk Ketorolac Tromethamine was left uncovered during transfer and filling in the ISO 5 compounding room.
        *   Operator practices during compounding: arm moving over sterile vials, hands dropping below airflow, resting on critical surfaces, and handling outside objects without re-sanitization.
        *   Materials transferred to critical work surface without sanitization.
    *   **Airflow and Facility Design:**
        *

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## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

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