Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-12-13.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Nov 2017 – 13 Dec 2017 | Human Drugs | 483 | On file |
| 18 Apr 2016 – 26 May 2016 | Human Drugs | 483 | View 483 → |
| 12 Jun 2015 – 13 Jul 2015 | Human Drugs | 483 | View 483 → |
| 20 Feb 2013 – 28 Feb 2013 | Human Drugs | 483 | View 483 → |
| 11 Jul 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 May 2016
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Nicholas A Violand, Mina Ahmadi, Barbara J Wilimczyk-Macri
26 May 2016
21 CFR 211.167(a)
Sterility/pyrogen-free testing
Cited by Nicholas A Violand, Mina Ahmadi, Barbara J Wilimczyk-Macri
26 May 2016
21 CFR 211.28(a)
Clothing appropriate for duties performed
Cited by Nicholas A Violand, Mina Ahmadi, Barbara J Wilimczyk-Macri
26 May 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Nicholas A Violand, Mina Ahmadi, Barbara J Wilimczyk-Macri
26 May 2016
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Nicholas A Violand, Mina Ahmadi, Barbara J Wilimczyk-Macri
Investigators
FDA investigators tied to this site in the record.
Nicholas A Violand2 insp.
Barbara J Wilimczyk-Macri2 insp.
Adetutu M Gidado1 insp.
Mina Ahmadi1 insp.
Russell J Glapion1 insp.
James A Liubicich1 insp.
Jose M Cayuela1 insp.
Paul L Bellamy1 insp.
Atul Agrawal1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | 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 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind PharMEDium Services, LLC's 4 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