Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
7 May 2013
21 CFR 211.84(d)(2)
Component written specification
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
7 May 2013
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
7 May 2013
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
7 May 2013
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
7 May 2013
21 CFR 211.166(c)(1)
Homeopathic drugs, assessment of stability
Cited by Marie B Buen-Bigornia, Kimberley A Hoefen
Inspected site
NVNew Vistas IncorporatedDenver, 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 | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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