Overview
- 4 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.
20 Jan 2010
21 CFR 820.100(a)(4)
CAPA verification/validation of corrective/preventive action
Cited by Andrea A Branche
Inspected site
TSTrilliant Surgical Ltd.Houston, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | 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