Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-10-08.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Aug 2021 – 8 Oct 2021 | Biologics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Oct 2021
21 CFR 58.185(a)(9)
Final report: circumstances affecting data qual., integrity
Cited by Sandra S Saniga, Diane C Van Leeuwen
8 Oct 2021
21 CFR 58.190(a)
Archives: data, documentation, specimens
Cited by Sandra S Saniga, Diane C Van Leeuwen
8 Oct 2021
21 CFR 58.29(b)
Personnel: summary of training, job description
Cited by Sandra S Saniga, Diane C Van Leeuwen
8 Oct 2021
21 CFR 58.33
study director: overall study responsibility
Cited by Sandra S Saniga, Diane C Van Leeuwen
8 Oct 2021
21 CFR 58.33(a)
Study director: follow study protocol
Cited by Sandra S Saniga, Diane C Van Leeuwen
Investigators
FDA investigators tied to this site in the record.
Sandra S Saniga1 insp.
Diane C Van Leeuwen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.185(a)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.29(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.63(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Valley Biosystems' 1 Form 483
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