Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2011-11-29.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Nov 2011 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Nov 2011
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Claudette D Brooks
29 Nov 2011
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Claudette D Brooks
Investigators
FDA investigators tied to this site in the record.
Claudette D Brooks1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Andersen Sterilizers Inc's 1 Form 483
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