Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-05-24.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 May 2022 – 24 May 2022 | Human Drugs | Clean | |
| 5 Apr 2017 – 12 Apr 2017 | Human Drugs | 483 | View 483 → |
| 25 Jan 2012 | Not recorded | Clean | |
| 23 Nov 2010 | Not recorded | 483 | View 483 → |
| 27 Apr 2009 | Not recorded | Clean | |
| 22 Dec 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Apr 2017
21 CFR 211.160(b)(4)
Written calibration procedures
Cited by Lindsey M Schwierjohann, Mary B Sheets
12 Apr 2017
21 CFR 211.160(b)(4)
Written calibration procedures
Cited by Lindsey M Schwierjohann, Mary B Sheets
12 Apr 2017
21 CFR 211.166(a)
Written program not followed
Cited by Lindsey M Schwierjohann, Mary B Sheets
12 Apr 2017
21 CFR 211.166(a)
Written program not followed
Cited by Lindsey M Schwierjohann, Mary B Sheets
12 Apr 2017
21 CFR 211.194(e)
Stability testing records not included
Cited by Lindsey M Schwierjohann, Mary B Sheets
Investigators
FDA investigators tied to this site in the record.
Steven P Eastham1 insp.
Wen Ning Chan1 insp.
Lindsey M Schwierjohann1 insp.
Mary B Sheets1 insp.
Tracey L Harris1 insp.
Samuel A Hamblin1 insp.
Anna M Brannen1 insp.
Elizabeth L Edwards1 insp.
Joshua S Hunt1 insp.
Nicholas L Paulin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kao USA 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