Overview
- 6 public-safe observations are available for this inspection.
- 3 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.
10 Jan 2020
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Eric J Heinze, Amogh Pathi
10 Jan 2020
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Eric J Heinze, Amogh Pathi
10 Jan 2020
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Eric J Heinze, Amogh Pathi
Inspected site
AVAvantec Vascular CorporationSunnyvale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
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 6 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