Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-12-15.
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 – 15 Dec 2017 | Human Drugs | 483 | View 483 → |
| 19 Jan 2016 – 21 Jan 2016 | Human Drugs | Clean | |
| 22 Jun 2015 – 10 Jul 2015 | Human Drugs | 483 | View 483 → |
| 18 Mar 2013 – 22 Mar 2013 | Human Drugs | 483 | View 483 → |
| 30 Sep 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Dec 2017
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jennifer L Huntington, June P Page, Neda Hamandi
15 Dec 2017
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jennifer L Huntington, June P Page, Neda Hamandi
15 Dec 2017
21 CFR 211.192
Quality control unit review of records
Cited by Jennifer L Huntington, June P Page, Neda Hamandi
15 Dec 2017
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Jennifer L Huntington, June P Page, Neda Hamandi
15 Dec 2017
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Jennifer L Huntington, June P Page, Neda Hamandi
Investigators
FDA investigators tied to this site in the record.
June P Page2 insp.
Zada L Giles2 insp.
Marvin D Jones2 insp.
Jennifer L Huntington1 insp.
Neda Hamandi1 insp.
Ivy E Sweeney1 insp.
Dell S Moller1 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 | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | 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)(10)(iv) | 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 211.46(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10) | 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