Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-04-05.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Apr 2019 – 5 Apr 2019 | Human Drugs | 483 | View 483 → |
| 24 Apr 2017 – 28 Apr 2017 | Human Drugs | 483 | View 483 → |
| 22 Aug 2016 – 26 Aug 2016 | Human Drugs | 483 | View 483 → |
| 23 Jul 2012 | Not recorded | 483 | View 483 → |
| 26 Jul 2011 | Not recorded | 483 | View 483 → |
| 17 Nov 2009 | Not recorded | Clean | |
| 1 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Apr 2019
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Mindy M Chou
28 Apr 2017
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by James M Mason, Cedar H Boakye, Yubing Tang
28 Apr 2017
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by James M Mason, Cedar H Boakye, Yubing Tang
Investigators
FDA investigators tied to this site in the record.
James M Mason2 insp.
Mindy M Chou1 insp.
Cedar H Boakye1 insp.
Yubing Tang1 insp.
Michael L Casner1 insp.
Anita R Michael1 insp.
Thomas J Arista1 insp.
Susan E Polifko1 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 | 5x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hercon Pharmaceuticals, 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