Gland Pharma Limited
FDA inspection history in Hyderabad, India, 2019 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2019: 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.
- 2019One Form 483, at Hyderabad, India.
- 2019The longest 483 on file: 4 observations over 4 pages at Hyderabad, India.
- 2023–24Two Form 483s, at Hyderabad, India.
Cited most
Across all Gland Pharma Limited observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42Design and construction features1
The complete Gland Pharma 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
Hyderabad, India
Three Form 483s · 2019 to 2024 · 9 observations
Latest: Form 483, Aug 2, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-02 | 483 Form 483 | Hyderabad, India | 3 | $99 |
| 2023-08-26 | 483 Form 483 | Hyderabad, India | 2 | $99 |
| 2019-11-07 | 483 Form 483 | Hyderabad, India | 4 | $99 |
Investigators on these documents
Dipesh K. Shah (1)Jeffrey P. Raimondi (1)Michael A. Charles (1)Roger F. Zabinski (1)
FEI number 3009864167 · most recent document Aug 2, 2024
About Gland Pharma Limited
How many FDA Form 483s has Gland Pharma Limited received?
FDA Intel has 3 Form 483s on file for Gland Pharma Limited; the most recent is dated Aug 2, 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 Aug 2, 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 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.