Overview
- 6 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Sep 2017
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
7 Sep 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
7 Sep 2017
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
7 Sep 2017
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
7 Sep 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Sean R Marcsisin, Christina A Capacci-Daniel, Yong Hu, Sharmista Chatterjee
Inspected site
VPVertex Pharmaceuticals IncorporatedBoston, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 6 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