Warning letter
Valley Biosystems: warning letter of Aug 3, 2022
FDA warning letter 632553 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 632553 |
|---|---|
| Company | Valley Biosystems |
| Subject | Bioresearch Monitoring Program |
| Issue date | Aug 3, 2022 |
| Posted date | Aug 9, 2022 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 58.130(e), 58, 58.33, 58.190(a), 58.120, 58.35(a), 58.35(b)(3), 58.185(a)(9) |
| Inspection city | West Sacramento |
| Inspection ZIP | 95605-2321 |
| Inspection start date | Aug 26, 2021 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: