Aurobindo Pharma Limited
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 Polepally, India.
- 2022One Form 483, at Polepally, Mahaboob Nagar, India.
- 2022The longest 483 on file: 6 observations over 13 pages at Polepally, Mahaboob Nagar, India.
Cited most
Across all Aurobindo Pharma Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.63Equipment design, size, and location1
The complete Aurobindo Pharma Limited 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
Polepally, Mahaboob Nagar, India
One Form 483 · 2022 · 6 observations
Latest: Form 483, May 10, 2022 →Polepally, India
One Form 483 · 2019 · 1 observation
Latest: Form 483, Sep 27, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-05-10 | 483 Form 483 | Polepally, Mahaboob Nagar, India | 6 | $99 |
| 2019-09-27 | 483 Form 483 | Polepally, India | 1 | $99 |
Investigators on these documents
Darren S. Brown (1)Emmanuel J. Ramos (1)Jogy George (1)Justin A. Boyd (1)Tamil Arasu (1)
FEI number 3007373532 · most recent document May 10, 2022
About Aurobindo Pharma Limited
How many FDA Form 483s has Aurobindo Pharma Limited received?
FDA Intel has 2 Form 483s on file for Aurobindo Pharma Limited; the most recent is dated May 10, 2022.
When was Aurobindo Pharma Limited last inspected by FDA?
The most recent FDA inspection document on file for Aurobindo Pharma Limited is a Form 483 dated May 10, 2022, for the site in Polepally, Mahaboob Nagar, India.
What did FDA cite at Aurobindo Pharma Limited?
The regulations cited most in the observations on file for Aurobindo Pharma Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.