Overview
- 20 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-12-23.
At a glance
Inspections
20
Form 483s
9
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Dec 2025 – 23 Dec 2025 | Human Drugs | 483 | On file |
| 27 Jan 2022 – 8 Feb 2022 | Human Drugs | 483 | On file |
| 19 Aug 2019 – 23 Aug 2019 | Human Drugs | Clean | |
| 20 May 2019 – 5 Jun 2019 | Human Drugs | 483 | View 483 → |
| 28 Feb 2017 – 16 Mar 2017 | Human Drugs | 483 | On file |
| 4 Jan 2016 – 5 Jan 2016 | Human Drugs | Clean | |
| 11 May 2015 – 4 Jun 2015 | Human Drugs | 483 | View 483 → |
| 11 May 2014 – 4 Jun 2014 | Human Drugs | 483 | On file |
| 6 Feb 2013 – 19 Feb 2013 | Human Drugs | 483 | On file |
| 4 Apr 2012 | Not recorded | Clean | |
| 4 May 2011 | Not recorded | Clean | |
| 7 Aug 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Jun 2015
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sony Mathews, Mindy M Chou
Investigators
FDA investigators tied to this site in the record.
Paul C Mouris4 insp.
Sony Mathews3 insp.
Mindy M Chou2 insp.
Kwong P Lee1 insp.
JoshRenzo N Ramilo1 insp.
Guerlain Ulysse1 insp.
Janet A Rajan1 insp.
Srinivas Chennamaneni1 insp.
Benton M Ketron1 insp.
Helen B Ricalde1 insp.
Tara K Carmody1 insp.
Kellie Leveille1 insp.
Demitria J Xiradakis1 insp.
Karen L Kosar1 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 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Strides Pharma, Inc.'s 9 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