Overview
- 14 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
16 Nov 2018
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Veronica Fuentes, Tamara J Henderson, Steven B Hertz
16 Nov 2018
21 CFR 211.101(d)
Component addition checked by 2nd person
Cited by Veronica Fuentes, Tamara J Henderson, Steven B Hertz
16 Nov 2018
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Veronica Fuentes, Tamara J Henderson, Steven B Hertz
16 Nov 2018
21 CFR 211.166(a)
Lack of written stability program
Cited by Veronica Fuentes, Tamara J Henderson, Steven B Hertz
16 Nov 2018
21 CFR 211.68(b)
Computer control of master formula records
Cited by Veronica Fuentes, Tamara J Henderson, Steven B Hertz
Inspected site
VBVERO BIOTECH INC.Atlanta, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.170(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(d) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 14 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