Gland Pharma Limited
FDA inspection history in Hyderabad, India, 2015 to 2024
- 6
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2019: one Form 483; 2022: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Three Form 483s, at Hyderabad, India.
- 2019The longest 483 on file: 7 observations over 6 pages at Hyderabad, India.
- 2022–24Three Form 483s, at Hyderabad, India.
Cited most
Across all Gland Pharma Limited observations on file
- 21 CFR 211.180General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.42(b)Design and construction features2
- 21 CFR 211.67(b)Equipment cleaning and maintenance2
- 21 CFR 211.113Control of microbiological contamination1
The complete Gland Pharma Limited file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Hyderabad, India
Six Form 483s · 2015 to 2024 · 15 observations
Latest: Form 483, Jul 25, 2024 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-25 | 483 Form 483 | Hyderabad, India | 2 | $99 |
| 2023-07-14 | 483 Form 483 | Hyderabad, India | 1 | $99 |
| 2022-08-25 | 483 Form 483 | Hyderabad, India | 1 | $99 |
| 2019-05-16 | 483 Form 483 | Hyderabad, India | 7 | $99 |
| 2017-02-03 | 483 Form 483 | Hyderabad, India | 2 | $99 |
| 2015-03-17 | 483 Form 483 | Hyderabad, India | 2 | $99 |
Investigators on these documents
Ademola O. Daramola (1)Alan P. Kurtzberg (1)Carla J. Lundi (1)Jeffrey P. Raimondi (1)Joshua J. Silvestri (1)Katherine D. Adams (1)Michael A. Charles (1)Roger F. Zabinski (1)Youkeun Kim (1)
FEI number 3002647489 · most recent document Jul 25, 2024
About Gland Pharma Limited
How many FDA Form 483s has Gland Pharma Limited received?
FDA Intel has 6 Form 483s on file for Gland Pharma Limited; the most recent is dated Jul 25, 2024.
When was Gland Pharma Limited last inspected by FDA?
The most recent FDA inspection document on file for Gland Pharma Limited is a Form 483 dated Jul 25, 2024, for the site in Hyderabad, India.
What did FDA cite at Gland Pharma Limited?
The regulations cited most in the observations on file for Gland Pharma Limited are 21 CFR 211.180 (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.42(b) (Design and construction features), 2 times.