Warning letter
Namsa: warning letter of Mar 23, 2018
FDA warning letter 544884 · Center for Devices and Radiological Health
Key facts
| Reference number | 544884 |
|---|---|
| Company | Namsa |
| Subject | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
| Issue date | Mar 23, 2018 |
| Posted date | Aug 14, 2018 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 58, 58.83, 58.202, 58.1(a), 58.33(b), 58.33(c), 58.130(c), 58.190(b), 58.33(a) |
| Inspection city | Minneapolis |
| Inspection ZIP | 55443-1911 |
| Inspection start date | Nov 1, 2017 |
| 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: