Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-03-05.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Mar 2018 | Foods & Cosmetics | Clean | |
| 21 Apr 2015 – 23 Apr 2015 | Human Drugs | 483 | View 483 → |
| 1 Jul 2014 | Human Drugs | Clean | |
| 29 Jan 2010 | Not recorded | 483 | On file |
| 15 Nov 2007 | Not recorded | Clean | |
| 6 May 2005 | Not recorded | Clean | |
| 30 Sep 2002 | Not recorded | Clean | |
| 1 Jun 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Apr 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Cheryl A Clausen, Richard A Lyght, Dell S Moller
23 Apr 2015
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Cheryl A Clausen, Richard A Lyght, Dell S Moller
23 Apr 2015
21 CFR 211.130(e)
Packaging line inspection before use
Cited by Cheryl A Clausen, Richard A Lyght, Dell S Moller
Investigators
FDA investigators tied to this site in the record.
David P King1 insp.
Cheryl A Clausen1 insp.
Richard A Lyght1 insp.
Dell S Moller1 insp.
Nicole E Knowlton1 insp.
Bill Tackett1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind International Laboratories, Inc.'s 2 Form 483s
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