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.
6 Nov 2009
21 CFR 820.72(a)
Equipment control activity documentation
Cited by Thai T Duong, Kimetha A King
6 Nov 2009
21 CFR 820.80(d)(1)
DMR required activities {see also 820.181}
Cited by Thai T Duong, Kimetha A King
6 Nov 2009
21 CFR 820.90(a)
Nonconforming product evaluation/investigation
Cited by Thai T Duong, Kimetha A King
Inspected site
SMShippert Medical TechnologiesCentennial, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | 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