Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Sep 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Michelle J Glembin, Mildred J Tures
1 Sep 2023
21 CFR 820.120
Lack of or inadequate procedures for labeling
Cited by Michelle J Glembin, Mildred J Tures
1 Sep 2023
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Michelle J Glembin, Mildred J Tures
1 Sep 2023
21 CFR 820.30(g)
Design validation - Risk analysis
Cited by Michelle J Glembin, Mildred J Tures
1 Sep 2023
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Michelle J Glembin, Mildred J Tures
Inspected site
AHAPN Health LLCWaukesha, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 9 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere