Aurobindo Pharma Limited
FDA inspection history across 2 sites, 2015 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Three Form 483s, at Hyderabad, India and Medchal, India.
- 2023One Form 483, at Medchal, India.
- 2023The longest 483 on file: 3 observations over 2 pages at Medchal, India.
Cited most
Across all Aurobindo Pharma Limited observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.56(a)Sanitation1
- 21 CFR 211.67(b)Equipment cleaning and maintenance1
The complete Aurobindo Pharma Limited 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
Medchal, India
Two Form 483s · 2019 to 2023 · 4 observations
Latest: Form 483, Jul 21, 2023 →Hyderabad, India
Two Form 483s · 2015 to 2017 · 3 observations
Latest: Form 483, Apr 18, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-21 | 483 Form 483 | Medchal, India | 3 | $99 |
| 2019-05-24 | 483 Form 483 | Medchal, India | 1 | $99 |
| 2017-04-18 | 483 Form 483 | Hyderabad, India | 1 | $99 |
| 2015-06-26 | 483 Form 483 | Hyderabad, India | 2 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Andrew Le (1)Angela E. Glenn (1)Arsen Karapetyan (1)Cheryl Clausen (1)Pratik S. Upadhyay (1)Sangeeta M. Khurana (1)
FEI number 3004021229 · most recent document Jul 21, 2023
About Aurobindo Pharma Limited
How many FDA Form 483s has Aurobindo Pharma Limited received?
FDA Intel has 4 Form 483s on file for Aurobindo Pharma Limited; the most recent is dated Jul 21, 2023.
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 Jul 21, 2023, for the site in Medchal, 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 211.160 (General requirements), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.