Eugia Pharma Specialities Limited
FDA inspection history across 3 sites, 2016 to 2026
- 7
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2017: one Form 483; 2018: two Form 483s; 2019: one Form 483; 2024: one warning letter and one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Five Form 483s, at Medak District, India and Sangareddy, India.
- 2019The longest 483 on file: 14 observations over 37 pages at Sangareddy, India.
- 2024–26Two Form 483s and one warning letter, at Hyderabad, India and Sangareddy, India.
Cited most
Across all Eugia Pharma Specialities Limited observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review4
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.194Laboratory records3
The complete Eugia Pharma Specialities Limited file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Medak District, India
Four Form 483s · 2016 to 2018 · 6 observations
Latest: Form 483, Dec 14, 2018 →Sangareddy, India
Three Form 483s · 2019 to 2026 · 34 observations
Latest: Form 483, Feb 6, 2026 →Hyderabad, India
One warning letter · 2024
Latest: Warning letter, Aug 15, 2024 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-06 | 483 Form 483 | Sangareddy, India | 11 | $99 |
| 2024-08-15 | Warning letter Warning letter | Hyderabad, India | — | $99 |
| 2024-02-02 | 483 Form 483 | Sangareddy, India | 9 | $99 |
| 2019-11-13 | 483 Form 483 | Sangareddy, India | 14 | $99 |
| 2018-12-14 | 483 Form 483 | Medak District, India | 1 | $99 |
| 2018-02-20 | 483 Form 483 | Medak District, India | 2 | $99 |
| 2017-04-28 | 483 Form 483 | Medak District, India | 1 | $99 |
| 2016-09-16 | 483 Form 483 | Medak District, India | 2 | $99 |
Investigators on these documents
Scott Ballard (2)Dipesh K. Shah (1)Eileen A. Liu (1)Freddy Ortiz Colon (1)Jose A. Cruz-Gonzalez (1)June P. Page (1)Justin A. Boyd (1)Lisa L. Flores (1)Marie B. Buen-Bigornia (1)Patty P. Kaewussdangkul (1)Saleem A. Akhtar (1)Thomas J. Arista (1)
FEI number 3008461619 · most recent document Feb 6, 2026
About Eugia Pharma Specialities Limited
How many FDA Form 483s has Eugia Pharma Specialities Limited received?
FDA Intel has 7 Form 483s on file for Eugia Pharma Specialities Limited; the most recent is dated Feb 6, 2026.
When was Eugia Pharma Specialities Limited last inspected by FDA?
The most recent FDA inspection document on file for Eugia Pharma Specialities Limited is a Form 483 dated Feb 6, 2026, for the site in Sangareddy, India.
What did FDA cite at Eugia Pharma Specialities Limited?
The regulations cited most in the observations on file for Eugia Pharma Specialities Limited are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 4 times.
Has Eugia Pharma Specialities Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Eugia Pharma Specialities Limited; the most recent is dated Aug 15, 2024.