Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-05.
At a glance
Inspections
9
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Apr 2024 – 5 Apr 2024 | Human Drugs | 483 | View 483 → |
| 20 Jan 2020 – 24 Jan 2020 | Human Drugs | Clean | |
| 5 Aug 2019 – 9 Aug 2019 | Human Drugs | Clean | |
| 21 Nov 2016 – 25 Nov 2016 | Human Drugs | 483 | On file |
| 2 Mar 2015 – 6 Mar 2015 | Human Drugs | 483 | View 483 → |
| 9 Sep 2013 – 13 Sep 2013 | Human Drugs | 483 | View 483 → |
| 17 Oct 2011 | Not recorded | 483 | On file |
| 9 Apr 2009 | Not recorded | Clean | |
| 5 Apr 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Apr 2024
21 CFR 211.188(b)(12)
Investigations made into any unexplained discrepancy
Cited by Steven A Brettler
6 Mar 2015
21 CFR 211.22(b)
Adequate lab facilities not available
Cited by Nicole E Knowlton, Walden H Lee
6 Mar 2015
21 CFR 211.52
Washing and toilet facilities are deficient
Cited by Nicole E Knowlton, Walden H Lee
13 Sep 2013
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Santos E Camara, Blondell W Johnson
Investigators
FDA investigators tied to this site in the record.
Steven A Brettler1 insp.
Bijoy Panicker1 insp.
Zhaoyang Meng1 insp.
Ross J Grigsby1 insp.
Ariel Cruz Figueroa1 insp.
Nicole E Knowlton1 insp.
Walden H Lee1 insp.
Santos E Camara1 insp.
Blondell W Johnson1 insp.
Mural B Gavini1 insp.
Larry K Austin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Strides Pharma Science Limited's 5 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