EUGIA Pharma Specialities Limited
FDA inspection history across 2 sites, 2018 to 2026
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2024: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Bhiwadi, India.
- 2024–26Two Form 483s and one warning letter, at Bhiwadi, India and Hyderabad, India.
- 2025The longest 483 on file: 9 observations over 14 pages.
Cited most
Across all EUGIA Pharma Specialities Limited observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.192Production record review1
- 21 CFR 211.25(a)Personnel qualifications1
The complete EUGIA Pharma Specialities Limited file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bhiwadi, India
Two Form 483s · 2018 to 2024 · 9 observations
Latest: Form 483, May 3, 2024 →Hyderabad, India
One warning letter · 2026
Latest: Warning letter, Aug 13, 2026 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-13 | Warning letter Warning letter | Hyderabad, India | — | $99 |
| 2025-11-14 | 483 Form 483 | — | 9 | $99 |
| 2024-05-03 | 483 Form 483 | Bhiwadi, India | 7 | $99 |
| 2018-03-06 | 483 Form 483 | Bhiwadi, India | 2 | $99 |
Investigators on these documents
Anastasia M. Shields (2)Angelica M. Hernandez (1)Carrie A. Hughes (1)Justin A. Boyd (1)Vaishali J. Patel (1)
FEI number 3009883410 · most recent document Aug 13, 2026
About EUGIA Pharma Specialities Limited
How many FDA Form 483s has EUGIA Pharma Specialities Limited received?
FDA Intel has 3 Form 483s on file for EUGIA Pharma Specialities Limited; the most recent is dated Nov 14, 2025.
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 Nov 14, 2025.
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 211.42(c)(10)(iv) (Design and construction features), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 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 13, 2026.