Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
21 Oct 2009
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Lorie S Hannappel, Charles D Brown
21 Oct 2009
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Lorie S Hannappel, Charles D Brown
21 Oct 2009
21 CFR 820.198(a)(1)
Uniform and timely processing
Cited by Lorie S Hannappel, Charles D Brown
Inspected site
EMEncore Medical, LPAustin, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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