Aurobindo Pharma Limited (Unit 1)
FDA inspection history in Doultabad, India, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Doultabad, India.
Cited most
Across all Aurobindo Pharma Limited (Unit 1) observations on file
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Aurobindo Pharma Limited (Unit 1) file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Doultabad, India
One Form 483 · 2021 · 7 observations
Latest: Form 483, Aug 12, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-12 | 483 Form 483 | Doultabad, India | 7 | $99 |
Investigators on these documents
About Aurobindo Pharma Limited (Unit 1)
How many FDA Form 483s has Aurobindo Pharma Limited (Unit 1) received?
FDA Intel has 1 Form 483 on file for Aurobindo Pharma Limited (Unit 1); the most recent is dated Aug 12, 2021.
When was Aurobindo Pharma Limited (Unit 1) last inspected by FDA?
The most recent FDA inspection document on file for Aurobindo Pharma Limited (Unit 1) is a Form 483 dated Aug 12, 2021, for the site in Doultabad, India.
What did FDA cite at Aurobindo Pharma Limited (Unit 1)?
The regulations cited most in the observations on file for Aurobindo Pharma Limited (Unit 1) are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.