Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-14.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 – 14 Nov 2025 | Human Drugs | 483 | View 483 → |
| 16 Oct 2024 – 25 Oct 2024 | Human Drugs | WL | View 483 → |
| 15 Sep 2021 – 23 Sep 2021 | Human Drugs | 483 | On file |
| 28 Aug 2018 – 25 Apr 2019 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Nov 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Rowena S Nguyen, Thuy Tram L Nguyen
14 Nov 2025
21 CFR 211.192
Written record of investigation incomplete
Cited by Rowena S Nguyen, Thuy Tram L Nguyen
14 Nov 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Rowena S Nguyen, Thuy Tram L Nguyen
Investigators
FDA investigators tied to this site in the record.
Rowena S Nguyen1 insp.
Thuy Tram L Nguyen1 insp.
Jazmine N Brown1 insp.
Sangeeta M Khurana1 insp.
Kenneth O Gee1 insp.
Christopher R Czajka1 insp.
Andrew K Haack1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10)(B) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind OSRX Inc.'s 4 Form 483s
Source PDFs 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