Gland Pharma Limited
FDA inspection history in Visakhapatnam, India, 2015 to 2019
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Three Form 483s, at Visakhapatnam, India.
- 2015The longest 483 on file: 12 observations over 7 pages at Visakhapatnam, India.
Cited most
Across all Gland Pharma Limited observations on file
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
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
Visakhapatnam, India
Three Form 483s · 2015 to 2019 · 18 observations
Latest: Form 483, Nov 1, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-01 | 483 Form 483 | Visakhapatnam, India | 2 | $99 |
| 2017-03-31 | 483 Form 483 | Visakhapatnam, India | 4 | $99 |
| 2015-06-30 | 483 Form 483 | Visakhapatnam, India | 12 | $99 |
Investigators on these documents
FEI number 3009056604 · most recent document Nov 1, 2019
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 Nov 1, 2019.
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 Nov 1, 2019, for the site in Visakhapatnam, 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), 8 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.160 (General requirements), 2 times.