Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2016-10-27.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Oct 2016 – 27 Oct 2016 | Human Drugs | 483 | View 483 → |
| 19 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Oct 2016
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Ashar P Parikh, James C Lee
27 Oct 2016
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Ashar P Parikh, James C Lee
27 Oct 2016
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Ashar P Parikh, James C Lee
27 Oct 2016
21 CFR 211.84(d)(3)
Establish reliability of supplier's C of A
Cited by Ashar P Parikh, James C Lee
Investigators
FDA investigators tied to this site in the record.
Ashar P Parikh1 insp.
James C Lee1 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 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kaiser Foundation Hospitals' 1 Form 483
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