# FDA 483 - Eugia Pharma Specialities Limited - February 20, 2018

Source: https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/a79eaef1-d0d8-477c-9fe3-124b321d92aa

> FDA 483 for Eugia Pharma Specialities Limited on February 20, 2018. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eugia Pharma Specialities Limited
- Inspection Date: 2018-02-20
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection, citing multiple deficiencies in the facility's operations and quality systems.

**Facility and Operations:** The inspection involved the manufacture of "REDACTED injection" in aseptic processing areas, including a vial washer and sterilizer, and a semi-finished product storage area.

**Violations and Observations:**
*   **Aseptic Processing Area Deficiencies:** Dirty "REDACTED" with black stains were observed on the filling machine during set-up and filling preparation for lot #REDACTED. Management was informed but took no action, and the dirty equipment remained in use.
*   **Equipment Cleaning and Maintenance:** "REDACTED" on the filling machine, used for aseptic interventions in the Grade A zone, had obvious built-up dirt and stains. These "REDACTED" had been in use since June 2017.
*   **Equipment Design and Qualification:** The qualification of the vial washer (Eq. Id. # L-PR-QASHM-001) and "REDACTED" for washing and sterilizing "REDACTED mL" vials was inadequate.
    *   The vial washer qualification failed to demonstrate bioburden removal from "REDACTED mL" glass vials.
    *   Qualification studies used a statistically unsound number of vials (less than 1% of a commercial lot size of "REDACTED" vials) to demonstrate cleaning and

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## Related Officers

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

Company: https://www.keypedia.com/companies/eugia-pharma-specialities-limited/9733456f-3189-4fe6-a4f9-327f0ce92559

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c