Overview
- 17 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-20.
At a glance
Inspections
17
Form 483s
12
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 May 2026 – 20 May 2026 | Human Drugs | 483 | On file |
| 5 Dec 2022 – 9 Dec 2022 | Human Drugs | 483 | On file |
| 2 Mar 2020 – 5 Mar 2020 | Not recorded | Clean | |
| 2 Mar 2020 – 5 Mar 2020 | Human Drugs | 483 | On file |
| 2 Mar 2020 – 5 Mar 2020 | Not recorded | Clean | |
| 2 Mar 2020 – 5 Mar 2020 | Human Drugs | 483 | View 483 → |
| 13 Jan 2020 – 17 Jan 2020 | Human Drugs | 483 | View 483 → |
| 16 May 2019 – 24 May 2019 | Human Drugs | 483 | View 483 → |
| 29 Oct 2018 – 2 Nov 2018 | Human Drugs | Clean | |
| 20 Aug 2018 – 24 Aug 2018 | Human Drugs | 483 | On file |
| 22 May 2017 – 26 May 2017 | Human Drugs | 483 | On file |
| 27 Jun 2016 – 30 Jun 2016 | Human Drugs | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Mar 2020
21 CFR 211.105(b)
Distinctive ID or code not recorded in batch record
Cited by Jennifer L Huntington
5 Mar 2020
21 CFR 211.105(b)
Distinctive ID or code not recorded in batch record
Cited by Jennifer L Huntington
17 Jan 2020
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Marcellinus D Dordunoo
Investigators
FDA investigators tied to this site in the record.
Jennifer L Huntington3 insp.
Lisa L Flores1 insp.
Rafeeq A Habeeb1 insp.
Jose E Melendez1 insp.
Pratik S Upadhyay1 insp.
Marcellinus D Dordunoo1 insp.
Rumany C Penn1 insp.
Steven P Donald1 insp.
Kejun Cheng1 insp.
Andrew J Idzior1 insp.
Tamil Arasu1 insp.
Darren S Brown1 insp.
Satheesh Thomas1 insp.
Scott T Ballard1 insp.
Katherine Szestypalow1 insp.
Eric M Mueller1 insp.
Parul M Patel1 insp.
Shirley J Berryman1 insp.
Simone E Pitts1 insp.
Mural B Gavini1 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 | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Strides Pharma Science Limited's 12 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