Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-29.
At a glance
Inspections
7
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Aug 2024 – 29 Aug 2024 | Human Drugs | Clean | |
| 29 Aug 2022 – 2 Sep 2022 | Human Drugs | 483 | View 483 → |
| 14 Mar 2022 – 15 Mar 2022 | Human Drugs | Clean | |
| 26 Aug 2019 – 30 Aug 2019 | Human Drugs | 483 | View 483 → |
| 24 Aug 2015 – 27 Aug 2015 | Human Drugs | Clean | |
| 20 Apr 2012 | Not recorded | Clean | |
| 14 Apr 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Sep 2022
21 CFR 211.110(a)
Written in-process control procedures
Cited by William J Leonard, Valerie L Whipp, Terry Bridgewater
2 Sep 2022
21 CFR 211.110(a)
Written in-process control procedures
Cited by William J Leonard, Valerie L Whipp, Terry Bridgewater
2 Sep 2022
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by William J Leonard, Valerie L Whipp, Terry Bridgewater
2 Sep 2022
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by William J Leonard, Valerie L Whipp, Terry Bridgewater
2 Sep 2022
21 CFR 211.166(b)
Adequate number of batches on stability
Cited by William J Leonard, Valerie L Whipp, Terry Bridgewater
Investigators
FDA investigators tied to this site in the record.
William J Leonard3 insp.
Valerie L Whipp2 insp.
Victoria Spivak1 insp.
Azeezat M Lawal1 insp.
Nelson N Ayangho1 insp.
Terry Bridgewater1 insp.
Michael L Casner1 insp.
Deborah J Parris1 insp.
Anita R Michael1 insp.
Hala L Selby1 insp.
John M Mastalski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sharp Clinical Services, LLC's 3 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