Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
14 Mar 2012
21 CFR 606.20(b)
Qualifications of responsible personnel
Cited by Sarah M Forney, Jennifer Macmillan
14 Mar 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Sarah M Forney, Jennifer Macmillan
14 Mar 2012
21 CFR 606.100(b)(4)
Relate products to the donor
Cited by Sarah M Forney, Jennifer Macmillan
Inspected site
VVitalantMontvale, United States
Inspection team
JMJennifer Macmillan
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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