Aarti Drugs Ltd.
FDA inspection history in Tarapur, India, 2013 to 2024
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2013: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter.
- 2024One Form 483, at Tarapur, India.
Cited most
Across all Aarti Drugs observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.180General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Aarti Drugs 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
Tarapur, India
One Form 483 · 2024 · 7 observations
Latest: Form 483, Sep 20, 2024 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-20 | 483 Form 483 | Tarapur, India | 7 | $99 |
| 2013-07-30 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3006418686 · most recent document Sep 20, 2024
About Aarti Drugs Ltd.
How many FDA Form 483s has Aarti Drugs Ltd. received?
FDA Intel has 1 Form 483 on file for Aarti Drugs Ltd.; the most recent is dated Sep 20, 2024.
When was Aarti Drugs Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Aarti Drugs Ltd. is a Form 483 dated Sep 20, 2024, for the site in Tarapur, India.
What did FDA cite at Aarti Drugs Ltd.?
The regulations cited most in the observations on file for Aarti Drugs Ltd. are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.180 (General requirements), 1 time.
Has Aarti Drugs Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Aarti Drugs Ltd.; the most recent is dated Jul 30, 2013.