# FDA 483 - EUGIA Pharma Specialities Limited - May 03, 2024

Source: https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/6fcb373a-04fe-4be3-b567-fac453141ee3

> FDA 483 for EUGIA Pharma Specialities Limited on May 03, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EUGIA Pharma Specialities Limited
- Inspection Date: 2024-05-03
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection of a pharmaceutical manufacturing facility. The facility produces sterile drug products, including injections and bulk APIs.

**Observation 1: Procedures to prevent microbiological contamination are not established and followed.**
*   During aseptic filling, personnel behavior procedures (EP2-PRD-SOP-002) and line-specific intervention procedures were not followed.
    *   Operators reached over the line, blocking laminar airflow, during assembly and filling of Injection, a practice linked to a contaminated vial in a 2022 media fill.
    *   Non-sterile tools were used for interventions, and operators placed hands/arms near sterile product.
    *   Manual manipulations during sterile canister change-outs involved operators reaching over the filling line and exposed stoppers.
    *   Operators touched open vials with non-sterile equipment, and these vials were subsequently filled.
    *   Operators used non-sterile equipment directly over sterile stoppers and surfaces.
    *   An operator's sterile gown had a hole during cleaning in Grade A/B areas.
    *   Sterile canisters were placed on a stool, not the designated cart, disrupting laminar airflow.
    *   During bulk API filling, operators leaned over sterile product and primary closures, disrupting laminar airflow.

**Observation 2: Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process.**
*   A repetitive, manually

## Related Documents

- [483 - 2018-03-06](https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/d9cb86c0-e5ad-44af-927a-41fd164955d9)
- [483 - 2024-05-03](https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/2100530d-b507-419b-8d24-6840d66f73b3)
- [483 - 2025-11-14](https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/75751173-cc77-4148-9d2c-be0ba4dbebec)

## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.keypedia.com/companies/eugia-pharma-specialities-limited/c9c73721-7ca2-4457-89c9-f1001123e141

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