Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-03-16.
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 |
|---|---|---|---|
| 18 Feb 2016 – 16 Mar 2016 | Human Drugs | 483 | View 483 → |
| 2 Apr 2014 – 8 Apr 2014 | Human Drugs | 483 | View 483 → |
| 5 Mar 2014 – 13 Mar 2014 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Mar 2016
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Emily J Orban, Emilie Kahn, Lisa T Michel, Gary C Pecic
16 Mar 2016
21 CFR 211.165(a)
Testing and release for distribution
Cited by Emily J Orban, Emilie Kahn, Lisa T Michel, Gary C Pecic
16 Mar 2016
21 CFR 211.167(a)
Sterility/pyrogen-free testing
Cited by Emily J Orban, Emilie Kahn, Lisa T Michel, Gary C Pecic
16 Mar 2016
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Emily J Orban, Emilie Kahn, Lisa T Michel, Gary C Pecic
16 Mar 2016
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Emily J Orban, Emilie Kahn, Lisa T Michel, Gary C Pecic
Investigators
FDA investigators tied to this site in the record.
Emily J Orban2 insp.
Emilie Kahn1 insp.
Lisa T Michel1 insp.
Gary C Pecic1 insp.
Meisha R Sampson1 insp.
Meisha R Waters1 insp.
Sarah M Meng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(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)(iii) | 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 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pharmakon Pharmaceuticals, 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