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

Source: https://www.keypedia.com/records/483/eugia-pharma-specialities-limited/f14c23c1-ae40-4de0-a50e-d0fdf9b80942

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

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## Details

- Record Type: 483
- Company Name: EUGIA Pharma Specialities Limited
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: EUGIA Pharma Specialities Limited, a sterile pharmaceutical manufacturer in Medchal-Malkajgiri District, India, was inspected by the FDA from February 16-27, 2026. The inspection revealed significant deficiencies in aseptic processing, including inadequate environmental monitoring, personnel practices, and a lack of aseptic process validation. Additionally, issues were noted in laboratory controls regarding visual inspection qualification and incomplete investigations into consumer complaints of glass particulates in sterile injectable products.

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## 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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8