Aurobindo Pharma Ltd.
FDA inspection history across 3 sites, 2015 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Hyderabad, India.
- 2015The longest 483 on file: 11 observations over 7 pages at Hyderabad, India.
- 2020One Form 483, at Medchal, India.
- 2025One Form 483, at Bachupallv, India.
Cited most
Across all Aurobindo Pharma observations on file
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.42Design and construction features2
The complete Aurobindo Pharma 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
Bachupallv, India
One Form 483 · 2025 · 8 observations
Latest: Form 483, Sep 5, 2025 →Medchal, India
One Form 483 · 2020
Latest: Form 483, Feb 21, 2020 →Hyderabad, India
One Form 483 · 2015 · 11 observations
Latest: Form 483, Jul 10, 2015 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-05 | 483 Form 483 | Bachupallv, India | 8 | $99 |
| 2020-02-21 | 483 Form 483 | Medchal, India | — | $99 |
| 2015-07-10 | 483 Form 483 | Hyderabad, India | 11 | $99 |
Investigators on these documents
Claudia M. Perez-Kasmarski (1)Eileen A. Liu (1)Joseph A. Piechocki (1)Tamil Arasu (1)Thomas J. Arista (1)
FEI number 3004446312 · most recent document Sep 5, 2025
About Aurobindo Pharma Ltd.
How many FDA Form 483s has Aurobindo Pharma Ltd. received?
FDA Intel has 3 Form 483s on file for Aurobindo Pharma Ltd.; the most recent is dated Sep 5, 2025.
When was Aurobindo Pharma Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Aurobindo Pharma Ltd. is a Form 483 dated Sep 5, 2025, for the site in Bachupallv, India.
What did FDA cite at Aurobindo Pharma Ltd.?
The regulations cited most in the observations on file for Aurobindo Pharma Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.