Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
13 Jan 2017
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Marc S Neubauer
13 Jan 2017
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Marc S Neubauer
13 Jan 2017
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Marc S Neubauer
Inspected site
TMTerumo Medical CorporationElkton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 8 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