Warning letter
American Preclinical Services: warning letter of Feb 12, 2019
FDA warning letter 562382 · Center for Devices and Radiological Health
Key facts
| Reference number | 562382 |
|---|---|
| Company | American Preclinical Services |
| Subject | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
| Issue date | Feb 12, 2019 |
| Posted date | Feb 19, 2019 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 58.33(a), 58, 58.83, 58.202, 58.1(a), 58.35(a), 58.90(d), 58.105(d) |
| Inspection city | Minneapolis |
| Inspection ZIP | 55433-6043 |
| Inspection start date | Mar 19, 2018 |
| 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: