Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-20.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2024 – 20 Sep 2024 | Human Drugs | 483 | View 483 → |
| 24 Jun 2024 – 28 Jun 2024 | Biologics | Clean | |
| 27 Feb 2017 – 10 Mar 2017 | Human Drugs | 483 | View 483 → |
| 12 May 2014 – 23 May 2014 | Human Drugs | 483 | View 483 → |
| 24 Aug 2012 | Not recorded | 483 | View 483 → |
| 27 Apr 2011 | Not recorded | 483 | View 483 → |
| 11 Dec 2009 | Not recorded | Clean | |
| 29 Aug 2008 | Not recorded | 483 | On file |
| 28 Aug 2002 | Not recorded | Clean | |
| 15 Sep 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Sep 2024
21 CFR 211.105(b)
Distinctive ID or code not recorded in batch record
Cited by Santos E Camara, Miguel A Martinez
20 Sep 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Santos E Camara, Miguel A Martinez
20 Sep 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Santos E Camara, Miguel A Martinez
20 Sep 2024
21 CFR 211.166(a)(1)
Sample size - test intervals
Cited by Santos E Camara, Miguel A Martinez
Investigators
FDA investigators tied to this site in the record.
Margaret M Annes2 insp.
Sharon K Thoma2 insp.
Sina Shojaee2 insp.
Santos E Camara1 insp.
Miguel A Martinez1 insp.
Sunitha K Rajaram1 insp.
Shawn E Larson1 insp.
Shatina R Alridge1 insp.
Lloyd D Payne1 insp.
Rose M Ashley1 insp.
Lucas B Leake1 insp.
Thomas J Arista1 insp.
Torrance J Slayton1 insp.
Blondell W Johnson1 insp.
Karen C Daugherty1 insp.
Tricia S Martinez1 insp.
Stephen D Brown1 insp.
Patrick D Stone1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(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 211.165(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)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Otsuka ICU Medical LLC's 6 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