Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-28.
At a glance
Inspections
9
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2024 – 28 Mar 2024 | Human Drugs | 483 | View 483 → |
| 12 Dec 2019 – 20 Dec 2019 | Human Drugs | 483 | View 483 → |
| 5 Mar 2018 – 13 Mar 2018 | Human Drugs | 483 | View 483 → |
| 7 Mar 2016 – 16 Mar 2016 | Human Drugs | 483 | View 483 → |
| 1 Aug 2014 – 8 Aug 2014 | Human Drugs | 483 | On file |
| 2 Aug 2013 – 12 Aug 2013 | Human Drugs | 483 | On file |
| 29 Sep 2011 | Not recorded | 483 | View 483 → |
| 17 Mar 2009 | Not recorded | Clean | |
| 9 Mar 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Mar 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jeffrey P Raimondi, Xiaokuang Lai
28 Mar 2024
21 CFR 211.160(b)(3)
Acceptance of drug products
Cited by Jeffrey P Raimondi, Xiaokuang Lai
28 Mar 2024
21 CFR 211.165(f)
Failing drug products not rejected
Cited by Jeffrey P Raimondi, Xiaokuang Lai
28 Mar 2024
21 CFR 211.180(b)
Record maintenance 1 year (except exempt OTC)
Cited by Jeffrey P Raimondi, Xiaokuang Lai
28 Mar 2024
21 CFR 211.192
No written record of investigation
Cited by Jeffrey P Raimondi, Xiaokuang Lai
Investigators
FDA investigators tied to this site in the record.
Jeffrey P Raimondi1 insp.
Xiaokuang Lai1 insp.
Jose F Velez1 insp.
Michael A Charles1 insp.
Sandra A Hughes1 insp.
Steven P Donald1 insp.
Marion Michaelis1 insp.
Justin A Boyd1 insp.
Christophe T Peters1 insp.
Regina T Brown1 insp.
Julianne C Mccullough1 insp.
Parul M Patel1 insp.
Paula M Laplant1 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 | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ONESOURCE SPECIALTY PHARMA LIMITED's 7 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