Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru
FDA inspection history across 2 sites, 2011 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2011: one warning letter; 2017: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter.
- 2017One Form 483, at Hyderabad, India.
- 2023One Form 483, at Sangareddy, India.
- 2023The longest 483 on file: 1 observation over 2 pages at Sangareddy, India.
Cited most
Across all Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru 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
Sangareddy, India
One Form 483 · 2023 · 1 observation
Latest: Form 483, Sep 29, 2023 →Hyderabad, India
One Form 483 · 2017 · 1 observation
Latest: Form 483, Sep 1, 2017 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-29 | 483 Form 483 | Sangareddy, India | 1 | $99 |
| 2017-09-01 | 483 Form 483 | Hyderabad, India | 1 | $99 |
| 2011-05-20 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Brandy N. Lepage (1)Jennifer L. Huntington (1)Robert M. Barbosa (1)
FEI number 3004021263 · most recent document Sep 29, 2023
About Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru
How many FDA Form 483s has Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru received?
FDA Intel has 2 Form 483s on file for Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru; the most recent is dated Sep 29, 2023.
When was Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru last inspected by FDA?
The most recent FDA inspection document on file for Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru is a Form 483 dated Sep 29, 2023, for the site in Sangareddy, India.
What did FDA cite at Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru?
The regulations cited most in the observations on file for Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time.
Has Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Aurobindo Pharma Limited, Unit VI Unit 6, Survey No. 329/39 & 329/47, Chitkul Village, Patancheru; the most recent is dated May 20, 2011.