Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-12.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Jul 2022 – 12 Aug 2022 | Human Drugs | 483 | View 483 → |
| 21 Oct 2019 – 24 Oct 2019 | Human Drugs | 483 | View 483 → |
| 13 Nov 2018 – 16 Nov 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
24 Oct 2019
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Veronica Fuentes, Laurie Nelson
Investigators
FDA investigators tied to this site in the record.
Veronica Fuentes2 insp.
Susan O Oladeji1 insp.
Dawn M Braswell1 insp.
Laurie Nelson1 insp.
Tamara J Henderson1 insp.
Steven B Hertz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 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 211.22(d) | 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 |
| 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 820.30(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind VERO BIOTECH INC.'s 3 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat