Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-22.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Nov 2024 – 22 Nov 2024 | Human Drugs | 483 | View 483 → |
| 6 Feb 2019 – 14 Feb 2019 | Human Drugs | WL | View 483 → |
| 28 Aug 2015 – 1 Sep 2015 | Human Drugs | 483 | View 483 → |
| 12 Aug 2013 – 22 Aug 2013 | Human Drugs | 483 | On file |
| 3 Feb 2011 | Not recorded | 483 | On file |
| 27 Feb 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Nov 2024
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Anastasia M Shields, Clinton J Lott
22 Nov 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Anastasia M Shields, Clinton J Lott
22 Nov 2024
21 CFR 211.68(b)
Computer control of master formula records
Cited by Anastasia M Shields, Clinton J Lott
14 Feb 2019
21 CFR 211.63
Equipment Design, Size and Location
Cited by Bijoy Panicker, Nicholas A Violand
1 Sep 2015
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters
Investigators
FDA investigators tied to this site in the record.
Regina T Brown2 insp.
Anastasia M Shields1 insp.
Clinton J Lott1 insp.
Bijoy Panicker1 insp.
Nicholas A Violand1 insp.
Felix Maldonado1 insp.
Meisha R Sampson1 insp.
Tajah L Blackburn1 insp.
Meisha R Waters1 insp.
Carla A Norris1 insp.
Sangeeta M Khurana1 insp.
Mark R Mcclain1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | 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 |
Full site report
Get the verbatim findings behind ONESOURCE SPECIALTY PHARMA LIMITED's 5 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