Cadila Healthcare Limited
FDA inspection history across 4 sites, 2018 to 2025
- 4
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2018: one Form 483; 2022: one Form 483; 2024: one warning letter and one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Vadodara-Halol Highway, India.
- 2022–25Three Form 483s and one warning letter, at Jarod, India; Ahmedabad, India and Village - Jarod, Taluka - Waghodia, India.
- 2024The longest 483 on file: 10 observations over 18 pages at Village - Jarod, Taluka - Waghodia, India.
Cited most
Across all Cadila Healthcare Limited observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.192Production record review2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
The complete Cadila Healthcare Limited file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Ahmedabad, India
One warning letter and one close-out letter · 2024
Latest: Warning letter, Aug 29, 2024 →Village - Jarod, Taluka - Waghodia, India
One Form 483 · 2024 · 10 observations
Latest: Form 483, Apr 23, 2024 →Jarod, India
One Form 483 · 2022 · 3 observations
Latest: Form 483, Mar 10, 2022 →Vadodara-Halol Highway, India
One Form 483 · 2018 · 1 observation
Latest: Form 483, Aug 28, 2018 →
Also: one document not tied to a site.
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-05 | 483 Form 483 | — | 4 | $99 |
| 2024-08-29 | Warning letter Warning letter | Ahmedabad, India | — | $99 |
| 2024-04-23 | 483 Form 483 | Village - Jarod, Taluka - Waghodia, India | 10 | $99 |
| 2022-03-10 | 483 Form 483 | Jarod, India | 3 | $99 |
| 2018-08-28 | 483 Form 483 | Vadodara-Halol Highway, India | 1 | $99 |
| Undated | Close-out Close-out letter | Ahmedabad, India | — | $99 |
Investigators on these documents
Anastasia M. Shields (1)Justin A. Boyd (1)Saleem A. Akhtar (1)Satheesh Thomas (1)
FEI number 3013712903 · most recent document Sep 5, 2025
About Cadila Healthcare Limited
How many FDA Form 483s has Cadila Healthcare Limited received?
FDA Intel has 4 Form 483s on file for Cadila Healthcare Limited; the most recent is dated Sep 5, 2025.
When was Cadila Healthcare Limited last inspected by FDA?
The most recent FDA inspection document on file for Cadila Healthcare Limited is a Form 483 dated Sep 5, 2025.
What did FDA cite at Cadila Healthcare Limited?
The regulations cited most in the observations on file for Cadila Healthcare Limited are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.42 (Design and construction features), 2 times.
Has Cadila Healthcare Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Cadila Healthcare Limited; the most recent is dated Aug 29, 2024.