Emcure Pharmaceuticals Limited
FDA inspection history in Ahmedabad, India, 2023 to 2026
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Ahmedabad, India.
- 2023The longest 483 on file: 5 observations over 4 pages at Ahmedabad, India.
- 2026One Form 483, at Ahmedabad, India.
Cited most
Across all Emcure Pharmaceuticals Limited observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.63Equipment design, size, and location1
The complete Emcure Pharmaceuticals Limited file.
All 2 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
Ahmedabad, India
Two Form 483s · 2023 to 2026 · 6 observations
Latest: Form 483, May 15, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-15 | 483 Form 483 | Ahmedabad, India | 1 | $99 |
| 2023-02-16 | 483 Form 483 | Ahmedabad, India | 5 | $99 |
Investigators on these documents
Brandy N. Lepage (1)Jessica S. Estriplet (1)Kellia N. Hicks (1)
FEI number 3014595023 · most recent document May 15, 2026
About Emcure Pharmaceuticals Limited
How many FDA Form 483s has Emcure Pharmaceuticals Limited received?
FDA Intel has 2 Form 483s on file for Emcure Pharmaceuticals Limited; the most recent is dated May 15, 2026.
When was Emcure Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Emcure Pharmaceuticals Limited is a Form 483 dated May 15, 2026, for the site in Ahmedabad, India.
What did FDA cite at Emcure Pharmaceuticals Limited?
The regulations cited most in the observations on file for Emcure Pharmaceuticals Limited are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.