Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
12 Feb 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Gregson A Joseph, Arie Menachem
12 Feb 2016
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Gregson A Joseph, Arie Menachem
12 Feb 2016
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Gregson A Joseph, Arie Menachem
12 Feb 2016
21 CFR 820.70(g)
Equipment design and installation
Cited by Gregson A Joseph, Arie Menachem
12 Feb 2016
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Gregson A Joseph, Arie Menachem
Inspected site
MVMedtronic Vascular Galway DBA Medtronic IrelandGalway, Ireland
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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