Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-11-30.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Sep 2021 – 30 Nov 2021 | Human Drugs | 483 | View 483 → |
| 4 Mar 2020 – 30 Mar 2020 | Human Drugs | 483 | View 483 → |
| 15 Feb 2018 – 8 Mar 2018 | Human Drugs | 483 | View 483 → |
| 3 Jan 2017 – 20 Jan 2017 | Human Drugs | 483 | View 483 → |
| 22 Jul 2014 – 20 Aug 2014 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Nov 2021
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Sean R Marcsisin, Erik W Koester
30 Nov 2021
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Sean R Marcsisin, Erik W Koester
30 Nov 2021
21 CFR 211.167(a)
Sterility/pyrogens - test methods written, followed
Cited by Sean R Marcsisin, Erik W Koester
30 Nov 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sean R Marcsisin, Erik W Koester
Investigators
FDA investigators tied to this site in the record.
Erik W Koester2 insp.
Edmund F Mrak2 insp.
Sean R Marcsisin1 insp.
John P Mistler1 insp.
Jonah S Ufferfilge1 insp.
Samir C Gala1 insp.
Niketa Patel1 insp.
Rachael A Moliver1 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 | 4x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| FDCA 503B(a)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(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 |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Edge Pharmacy Services, LLC'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