# FDA 483 - Eugia SEZ Private Limited - February 29, 2024

Source: https://www.keypedia.com/records/483/eugia-sez-private-limited/c9950ab3-3852-4ab3-a977-1234b0111d75

> FDA 483 for Eugia SEZ Private Limited on February 29, 2024. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eugia SEZ Private Limited
- Inspection Date: 2024-02-29
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: The FDA Form 483 details observations from an inspection of a facility manufacturing sterile drug products, specifically Injection USP.

**Violations and Observations:**

*   **Aseptic Processing Deficiencies:**
    *   Failure to follow procedures EP4-PR-SOP-042 (Aseptic Area Guidelines) and EP4-MB-SOP-028 (Viable Monitoring Program).
    *   Interventions into critical areas during aseptic manufacturing (e.g., removing stuck vials, passing items, cleaning) were not replicated during aseptic process simulations to assess risk.
    *   Operators failed to perform personnel monitoring after interventions into critical areas as mandated by EP4-MB-SOP-028.
    *   Lack of slow and deliberate movements during interventions, contrary to aseptic process simulation techniques.
    *   Failure to sanitize areas after interventions or clear manipulated vials from the line.
    *   No disinfectant efficacy study for tubing used for drug product transfer in the Grade A filling area.
    *   No written procedure for cleaning step ladders and Laminar Airflow Cabinets in Grade A and B areas, and no routine monitoring of these items. Microbial growth was observed on a step ladder sample.

*   **Quality Control and Data Integrity Issues:**
    *   Failure to follow SOP-HO-CQA-SOP-072 (Enumeration of Microbial Colonies); a personnel monitoring plate with one

## Related Documents

- [483 - 2018-05-04](https://www.keypedia.com/records/483/eugia-sez-private-limited/9d6255cf-d0c7-42ab-8453-18416bd4cf5b)
- [483 - 2019-03-01](https://www.keypedia.com/records/483/eugia-sez-private-limited/d2dfde51-d58c-479f-b72e-13a40c55f344)
- [483 - 2019-03-01](https://www.keypedia.com/records/483/eugia-sez-private-limited/cb641586-ada5-4f78-bdf8-443b3c625895)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)
- [Ashar P. Parikh](https://www.keypedia.com/people/ashar-p-parikh/f5430c51-31c7-44bb-90f7-1ec8ae581343)

Company: https://www.keypedia.com/companies/eugia-sez-private-limited/c458dd25-5620-40af-93fe-f25936ff47e8

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe