Warning letter
Fujifilm Medical Systems U.S.A., Inc.: warning letter of Aug 12, 2015
FDA warning letter 470470 · Center for Devices and Radiological Health
Key facts
| Reference number | 470470 |
|---|---|
| Company | Fujifilm Medical Systems U.S.A., Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 12, 2015 |
| Posted date | Aug 17, 2015 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 806.10(a)(1), 820 |
| Inspection city | Wayne |
| Inspection ZIP | 07470 |
| Inspection start date | Mar 24, 2015 |
| Letter on fda.gov | web.archive.org |
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: