Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-03-24.
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 |
|---|---|---|---|
| 14 Mar 2022 – 24 Mar 2022 | Human Drugs | 483 | View 483 → |
| 26 Aug 2015 – 29 Sep 2015 | Human Drugs | 483 | View 483 → |
| 9 Nov 2012 – 11 Feb 2013 | Human Drugs | WL | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Mar 2022
FDCA 501(a)(2)(A)
Disinfectant contact time
Cited by Sean R Marcsisin, Kristina L Conroy, Leanna M Slarsky
24 Mar 2022
FDCA 501(a)(2)(A)
Disruption of airflow from personnel movement
Cited by Sean R Marcsisin, Kristina L Conroy, Leanna M Slarsky
24 Mar 2022
FDCA 501(a)(2)(A)
Exposure of personnel in aspectic processing
Cited by Sean R Marcsisin, Kristina L Conroy, Leanna M Slarsky
24 Mar 2022
FDCA 501(a)(2)(A)
Inadequate HEPA filter, sterile product area
Cited by Sean R Marcsisin, Kristina L Conroy, Leanna M Slarsky
24 Mar 2022
FDCA 501(a)(2)(A)
Non-microbial contamination, production area
Cited by Sean R Marcsisin, Kristina L Conroy, Leanna M Slarsky
Investigators
FDA investigators tied to this site in the record.
Sean R Marcsisin1 insp.
Kristina L Conroy1 insp.
Leanna M Slarsky1 insp.
Russell J Glapion1 insp.
Thomas E Friel1 insp.
Nicholas A Violand1 insp.
Juanita P Versace1 insp.
Barbara J Wilimczyk-Macri1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 12x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | 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 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Wedgewood Village Pharmacy, Inc.'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