Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-05-27.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 May 2022 – 27 May 2022 | Human Drugs | 483 | On file |
| 21 Jul 2016 – 25 Jul 2016 | Human Drugs | 483 | View 483 → |
| 20 Aug 2012 | Not recorded | Clean | |
| 9 Sep 2009 | Not recorded | Clean | |
| 23 Sep 2008 | Not recorded | Clean | |
| 16 Jan 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2016
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by William J Leonard
Investigators
FDA investigators tied to this site in the record.
Timothy T Kapsala2 insp.
Nathaniel B Phillips Sylvain1 insp.
Hung H Do1 insp.
William J Leonard1 insp.
David P Vanhouten1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Omya 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