Overview
- 24 public-safe observations are available for this inspection.
- 8 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.
10 Jan 2017
21 CFR 820.150
Lack of or inadequate procedures for storage.
Cited by Claudette D Brooks, Christopher B May
10 Jan 2017
21 CFR 820.22
Quality Audits - defined intervals
Cited by Claudette D Brooks, Christopher B May
10 Jan 2017
21 CFR 820.30(f)
Design verification - documentation
Cited by Claudette D Brooks, Christopher B May
10 Jan 2017
21 CFR 820.30(g)
Design validation - documentation
Cited by Claudette D Brooks, Christopher B May
Inspected site
TITripath Imaging, Inc.Burlington, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.150 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 24 observations
The full inspection record, as Atlas holds it, 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