Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-11-21.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2014 – 21 Nov 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jul 2014 – 1 Aug 2014 | Human Drugs | 483 | View 483 → |
| 31 May 2012 | Not recorded | 483 | View 483 → |
| 15 Sep 2008 | Not recorded | Clean | |
| 12 May 2005 | Not recorded | Clean | |
| 3 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Nov 2014
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
Cited by Holly S Simms
1 Aug 2014
21 CFR 111.113(a)(1)
QC production, process control; material review, disposition
Cited by Jonathan W Chapman, Liatte Krueger
1 Aug 2014
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jonathan W Chapman, Liatte Krueger
Investigators
FDA investigators tied to this site in the record.
Holly S Simms1 insp.
Jonathan W Chapman1 insp.
Liatte Krueger1 insp.
Rachel C Harrington1 insp.
Nebil A Oumer1 insp.
Gale L Glinecki1 insp.
Edward P Potter1 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 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Konsyl 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