Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal
FDA inspection history across 3 sites, 2018 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2018: two Form 483s; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018Two Form 483s, at Sanga Reddy District, India and Sanga Reddy District Telangana, India.
- 2021–23Two Form 483s, at Sangareddy, India.
- 2021The longest 483 on file: 7 observations over 7 pages at Sangareddy, India.
Cited most
Across all Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.166Stability testing1
The complete Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal 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
Sangareddy, India
Two Form 483s · 2021 to 2023 · 11 observations
Latest: Form 483, Sep 8, 2023 →Sanga Reddy District, India
One Form 483 · 2018 · 1 observation
Latest: Form 483, Sep 28, 2018 →Sanga Reddy District Telangana, India
One Form 483 · 2018 · 4 observations
Latest: Form 483, Sep 28, 2018 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-08 | 483 Form 483 | Sangareddy, India | 4 | $99 |
| 2021-08-12 | 483 Form 483 | Sangareddy, India | 7 | $99 |
| 2018-09-28 | 483 Form 483 | Sanga Reddy District, India | 1 | $99 |
| 2018-09-28 | 483 Form 483 | Sanga Reddy District Telangana, India | 4 | $99 |
Investigators on these documents
FEI number 3004378446 · most recent document Sep 8, 2023
About Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal
How many FDA Form 483s has Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal received?
FDA Intel has 4 Form 483s on file for Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal; the most recent is dated Sep 8, 2023.
When was Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal last inspected by FDA?
The most recent FDA inspection document on file for Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal is a Form 483 dated Sep 8, 2023, for the site in Sangareddy, India.
What did FDA cite at Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?
The regulations cited most in the observations on file for Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.192 (Production record review), 3 times.