Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-28.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Mar 2025 – 28 Mar 2025 | Human Drugs | 483 | View 483 → |
| 29 Aug 2022 – 1 Sep 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Jul 2022 – 19 Jul 2022 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Mar 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anastasia M Shields, Alan A Rivera
28 Mar 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Anastasia M Shields, Alan A Rivera
28 Mar 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Anastasia M Shields, Alan A Rivera
28 Mar 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Anastasia M Shields, Alan A Rivera
Investigators
FDA investigators tied to this site in the record.
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 211.100(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 211.22(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 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ONESOURCE SPECIALTY PHARMA LIMITED's 3 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