Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
12 Aug 2022
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Susan O Oladeji, Dawn M Braswell
12 Aug 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Susan O Oladeji, Dawn M Braswell
12 Aug 2022
21 CFR 211.68(b)
Computer control of master formula records
Cited by Susan O Oladeji, Dawn M Braswell
12 Aug 2022
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Susan O Oladeji, Dawn M Braswell
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 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 4 observations
The source PDF, 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