Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-15.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Mar 2024 – 15 Mar 2024 | Human Drugs | 483 | View 483 → |
| 30 Jan 2019 – 2 Feb 2019 | Human Drugs | Clean | |
| 6 Nov 2017 – 17 Nov 2017 | Human Drugs | WL | On file |
| 9 May 2016 – 20 May 2016 | Human Drugs | 483 | On file |
| 23 Jun 2014 – 1 Jul 2014 | Human Drugs | WL | View 483 → |
| 8 Jul 2013 – 12 Jul 2013 | Human Drugs | 483 | View 483 → |
| 22 Jun 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Mar 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jeffrey P Raimondi, Aditi Thakur, Richmond K Yip
15 Mar 2024
21 CFR 211.192
No written record of investigation
Cited by Jeffrey P Raimondi, Aditi Thakur, Richmond K Yip
15 Mar 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey P Raimondi, Aditi Thakur, Richmond K Yip
1 Jul 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Peter E Baker, Parul M Patel, Thomas J Arista
1 Jul 2014
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Peter E Baker, Parul M Patel, Thomas J Arista
Investigators
FDA investigators tied to this site in the record.
Aditi Thakur2 insp.
Jeffrey P Raimondi1 insp.
Richmond K Yip1 insp.
Janete F Guardia1 insp.
Rebecca E Dombrowski1 insp.
Sandra A Hughes1 insp.
Helen B Ricalde1 insp.
Luis M Burgos Medero1 insp.
Peter E Baker1 insp.
Parul M Patel1 insp.
Thomas J Arista1 insp.
Jose A Lopez Rubet1 insp.
Anita Narula1 insp.
Michael R Goga1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Apotex Research Private Limited's 6 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat