# FDA 483 - EUGIA Pharma Specialities Limited - February 27, 2026

Source: https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/07d7a350-2647-4ba8-823d-bd19df956308

> FDA 483 for EUGIA Pharma Specialities Limited on February 27, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EUGIA Pharma Specialities Limited
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: From February 16 to February 27, 2026, the FDA conducted an inspection of the EUGIA Pharma Specialities Limited facility in Telangana, India. The resulting report outlines several critical concerns regarding the manufacturer"s ability to ensure the sterility and safety of its pharmaceutical products. Primary violations include inadequate procedures for preventing microbiological contamination. Specifically, the facility failed to maintain appropriate environmental monitoring during sterile transfers and exhibited poor aseptic techniques, such as operators touching sterile equipment surfaces with non-sanitized clothing. Furthermore, the firm had not performed essential production simulations (media fills) for certain processes since 2022, despite continuing to ship those products to the U.S. market. Additional issues were identified in the qualification of staff responsible for visual inspections, who were not regularly re-evaluated for accuracy or performance under typical working conditions. The FDA also noted a failure to thoroughly investigate serious product defects, including multiple consumer complaints regarding glass fragments found inside vials and recurring issues with container seals that were never systematically reviewed for suitability. These findings represent significant deviations from standard manufacturing quality requirements. EUGIA Pharma is required to provide a detailed response to the FDA outlining its corrective actions. This must include improved monitoring protocols, updated staff training, and a comprehensive re-evaluation of its investigation procedures to ensure that all quality discrepancies are fully resolved before products are distributed.

## Related Documents

- [483 - 2019-08-28](https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/8722eaf2-072f-4019-b613-fbfdbdade1d9)
- [WARNING_LETTER - 2024-02-02](https://www.keypedia.com/records/warning_letter/eugia-pharma-specialities-limited/d86a559b-cf18-4fd5-8e95-a2b3f62154d0)
- [483 - 2026-02-27](https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/f14c23c1-ae40-4de0-a50e-d0fdf9b80942)
- [483 - 2026-02-27](https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/e32e345e-6b51-40f5-96bb-8b248260c38c)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/eugia-pharma-specialities-limited/7c9f680c-5d29-42a0-a496-02fd4761792b

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa