Apotex Research Private Limited
FDA inspection history across 2 sites, 2015 to 2018
- 2
- Close-outs
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2015: one warning letter; 2016: one close-out letter; 2017: one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two close-out letters, one warning letter and one Form 483, at Bengaluru, India and Bangalore, India.
Cited most
Across all Apotex Research Private Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.142Warehousing procedures1
The complete Apotex Research Private 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
Bengaluru, India
One Form 483, one close-out letter and one warning letter · 2015 to 2017
Latest: Form 483, Nov 17, 2017 →Bangalore, India
One close-out letter · 2018
Latest: Close-out, Aug 9, 2018 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-09 | Close-out Close-out letter | Bangalore, India | — | $99 |
| 2017-11-17 | 483 Form 483 | Bengaluru, India | — | $99 |
| 2016-12-20 | Close-out Close-out letter | Bengaluru, India | — | $99 |
| 2015-01-30 | Warning letter Warning letter | Bengaluru, India | — | $99 |
FEI number 3006076314 · most recent document Aug 9, 2018
About Apotex Research Private Limited
How many FDA Form 483s has Apotex Research Private Limited received?
FDA Intel has 1 Form 483 on file for Apotex Research Private Limited; the most recent is dated Nov 17, 2017.
When was Apotex Research Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Apotex Research Private Limited is a Form 483 dated Nov 17, 2017, for the site in Bengaluru, India.
What did FDA cite at Apotex Research Private Limited?
The regulations cited most in the observations on file for Apotex Research Private Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.
Has Apotex Research Private Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Apotex Research Private Limited; the most recent is dated Jan 30, 2015.