Overview
- 13 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Dec 2010
21 CFR 803.50(a)(2)
Report of Malfunction
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
17 Dec 2010
21 CFR 803.52(b)(1)
Adverse Event of Product Problem
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
17 Dec 2010
21 CFR 803.52(f)(1)
Type of Reportable Event
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
17 Dec 2010
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
17 Dec 2010
21 CFR 820.30(f)
Design verification - documentation
Cited by Donna L Besone, Scott K Zika, Karen L Bauer
Inspected site
ASAdvanced Sterilization ProductsIrvine, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 observations
Every observation in full, 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