Intas Pharmaceuti cal s Li mi ted
FDA inspection history across 2 sites, 2023 to 2026
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2023: 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.
- 2023–26Three Form 483s and one warning letter, at Selaqui, India and Dehradun, India.
- 2024The longest 483 on file: 8 observations over 8 pages at Selaqui, India.
Cited most
Across all Intas Pharmaceuti cal s Li mi ted observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.42Design and construction features2
The complete Intas Pharmaceuti cal s Li mi ted 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
Selaqui, India
Two Form 483s · 2023 to 2024 · 15 observations
Latest: Form 483, Jan 24, 2024 →Dehradun, India
One Form 483 · 2025 · 3 observations
Latest: Form 483, Sep 17, 2025 →
Also: one document not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-30 | Warning letter Warning letter | — | — | $99 |
| 2025-09-17 | 483 Form 483 | Dehradun, India | 3 | $99 |
| 2024-01-24 | 483 Form 483 | Selaqui, India | 8 | $99 |
| 2023-01-20 | 483 Form 483 | Selaqui, India | 7 | $99 |
Investigators on these documents
Tamil Arasu (2)Arsen Karapetyan (1)Jeffrey P. Raimondi (1)Patty P. Kaewussdangkul (1)Saleem A. Akhtar (1)Teresa I. Navas (1)
FEI number 3005890633 · most recent document Mar 30, 2026
About Intas Pharmaceuti cal s Li mi ted
How many FDA Form 483s has Intas Pharmaceuti cal s Li mi ted received?
FDA Intel has 3 Form 483s on file for Intas Pharmaceuti cal s Li mi ted; the most recent is dated Sep 17, 2025.
When was Intas Pharmaceuti cal s Li mi ted last inspected by FDA?
The most recent FDA inspection document on file for Intas Pharmaceuti cal s Li mi ted is a Form 483 dated Sep 17, 2025, for the site in Dehradun, India.
What did FDA cite at Intas Pharmaceuti cal s Li mi ted?
The regulations cited most in the observations on file for Intas Pharmaceuti cal s Li mi ted are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times.
Has Intas Pharmaceuti cal s Li mi ted received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Intas Pharmaceuti cal s Li mi ted; the most recent is dated Mar 30, 2026.