Aurobindo Pharma, Ltd. Unit 01
FDA inspection history across 3 sites, 2016 to 2022
- 3
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2016: one Form 483; 2019: one Form 483; 2021: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Borpatla Village, India.
- 2019–22Two Form 483s and one warning letter, at Sangareddy, India and Hyderabad, India.
- 2021The longest 483 on file: 7 observations over 6 pages at Sangareddy, India.
Cited most
Across all Aurobindo Pharma, Ltd. Unit 01 observations on file
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.192Production record review2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Aurobindo Pharma, Ltd. Unit 01 file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Hyderabad, India
One warning letter and one close-out letter · 2022
Latest: Warning letter, Jan 12, 2022 →Sangareddy, India
Two Form 483s · 2019 to 2021 · 13 observations
Latest: Form 483, Aug 12, 2021 →Borpatla Village, India
One Form 483 · 2016 · 1 observation
Latest: Form 483, Oct 25, 2016 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-12 | Warning letter Warning letter | Hyderabad, India | — | $99 |
| 2021-08-12 | 483 Form 483 | Sangareddy, India | 7 | $99 |
| 2019-02-02 | 483 Form 483 | Sangareddy, India | 6 | $99 |
| 2016-10-25 | 483 Form 483 | Borpatla Village, India | 1 | $99 |
| Undated | Close-out Close-out letter | Hyderabad, India | — | $99 |
Investigators on these documents
Bapu Gaddam (1)Dipesh K. Shah (1)Rita K. Kabaso (1)Steven P. Donald (1)
FEI number 3004021253 · most recent document Jan 12, 2022
About Aurobindo Pharma, Ltd. Unit 01
How many FDA Form 483s has Aurobindo Pharma, Ltd. Unit 01 received?
FDA Intel has 3 Form 483s on file for Aurobindo Pharma, Ltd. Unit 01; the most recent is dated Aug 12, 2021.
When was Aurobindo Pharma, Ltd. Unit 01 last inspected by FDA?
The most recent FDA inspection document on file for Aurobindo Pharma, Ltd. Unit 01 is a Form 483 dated Aug 12, 2021, for the site in Sangareddy, India.
What did FDA cite at Aurobindo Pharma, Ltd. Unit 01?
The regulations cited most in the observations on file for Aurobindo Pharma, Ltd. Unit 01 are 21 CFR 211.100 (Written procedures; deviations), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.192 (Production record review), 2 times.
Has Aurobindo Pharma, Ltd. Unit 01 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Aurobindo Pharma, Ltd. Unit 01; the most recent is dated Jan 12, 2022.