Granul es India Limited
FDA inspection history across 2 sites, 2023 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Two Form 483s and one warning letter, at Medchal-Malkajgiri District, India and Medchal-Malkhajgiri District, India.
- 2024The longest 483 on file: 5 observations over 28 pages at Medchal-Malkhajgiri District, India.
Cited most
Across all Granul es India Limited observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Granul es India Limited file.
All 3 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
Medchal-Malkhajgiri District, India
One Form 483 · 2024 · 5 observations
Latest: Form 483, Sep 6, 2024 →Medchal-Malkajgiri District, India
One Form 483 · 2023 · 3 observations
Latest: Form 483, Jan 13, 2023 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-26 | Warning letter Warning letter | — | — | $99 |
| 2024-09-06 | 483 Form 483 | Medchal-Malkhajgiri District, India | 5 | $99 |
| 2023-01-13 | 483 Form 483 | Medchal-Malkajgiri District, India | 3 | $99 |
Investigators on these documents
FEI number 3004097901 · most recent document Feb 26, 2025
About Granul es India Limited
How many FDA Form 483s has Granul es India Limited received?
FDA Intel has 2 Form 483s on file for Granul es India Limited; the most recent is dated Sep 6, 2024.
When was Granul es India Limited last inspected by FDA?
The most recent FDA inspection document on file for Granul es India Limited is a Form 483 dated Sep 6, 2024, for the site in Medchal-Malkhajgiri District, India.
What did FDA cite at Granul es India Limited?
The regulations cited most in the observations on file for Granul es India Limited are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has Granul es India Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Granul es India Limited; the most recent is dated Feb 26, 2025.