Apotex Research Private Limited — FDA Facility Profile
Apotex Research Private Limited is an FDA-registered facility (FEI 3006076314) located in Bengaluru, IN. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 8 FDA inspections and 2 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- Mar 15, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (2 OAI, 5 VAI, 1 NAI)
- Last OAI inspection
- Nov 17, 2017
- Warning letters
- 2 listed by FDA for this FEI, latest Aug 9, 2018
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 15, 2024 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 2, 2019 | No Action Indicated (NAI) | No citations listed |
| Nov 17, 2017 | Official Action Indicated (OAI) | No citations listed |
| May 20, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 1, 2014 | Official Action Indicated (OAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Absence of Written Procedures (21 CFR 211.100(a)) Procedures for non-sterile drug products (21 CFR 211.113(a)) Investigations of discrepancies, failures (21 CFR 211.192) |
| Jul 12, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 22, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 17, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Apotex Research Private Limited
- Location
- Bengaluru (IN)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; MANUFACTURE
- Source
- decrs