Aurobindo Pharma Limited Unit lX
FDA inspection history across 2 sites, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Sangareddy, India.
- 2019The longest 483 on file: 5 observations over 7 pages at Sangareddy, India.
- 2022One Form 483, at Hatnoora Mandal Sangareddy, India.
Cited most
Across all Aurobindo Pharma Limited Unit lX observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Aurobindo Pharma Limited Unit lX file.
All 2 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
Hatnoora Mandal Sangareddy, India
One Form 483 · 2022 · 1 observation
Latest: Form 483, Nov 18, 2022 →Sangareddy, India
One Form 483 · 2019 · 5 observations
Latest: Form 483, Feb 2, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-18 | 483 Form 483 | Hatnoora Mandal Sangareddy, India | 1 | $99 |
| 2019-02-02 | 483 Form 483 | Sangareddy, India | 5 | $99 |
Investigators on these documents
FEI number 3006370489 · most recent document Nov 18, 2022
About Aurobindo Pharma Limited Unit lX
How many FDA Form 483s has Aurobindo Pharma Limited Unit lX received?
FDA Intel has 2 Form 483s on file for Aurobindo Pharma Limited Unit lX; the most recent is dated Nov 18, 2022.
When was Aurobindo Pharma Limited Unit lX last inspected by FDA?
The most recent FDA inspection document on file for Aurobindo Pharma Limited Unit lX is a Form 483 dated Nov 18, 2022, for the site in Hatnoora Mandal Sangareddy, India.
What did FDA cite at Aurobindo Pharma Limited Unit lX?
The regulations cited most in the observations on file for Aurobindo Pharma Limited Unit lX are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time.