Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
6 Jul 2017
21 CFR 1271.160(b)(6)
Deviations--evaluation, cause, corrective action
Cited by Ivan E Reyes, Shavon L Square, Colleen M Aspinwall
6 Jul 2017
21 CFR 1271.230(a)
Validation & approval--established procedures
Cited by Ivan E Reyes, Shavon L Square, Colleen M Aspinwall
6 Jul 2017
21 CFR 1271.200(d)
Inspected routinely
Cited by Ivan E Reyes, Shavon L Square, Colleen M Aspinwall
6 Jul 2017
21 CFR 1271.220(a)
Causing contamination, increasing risks
Cited by Ivan E Reyes, Shavon L Square, Colleen M Aspinwall
Inspected site
VBVivex Biologics, Inc.Miami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.220(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 observations
The source PDF and 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