Warning letter
Boule Medical AB: warning letter of Oct 2, 2018
FDA warning letter 559614 · Center for Devices and Radiological Health
Key facts
| Reference number | 559614 |
|---|---|
| Company | Boule Medical AB |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Oct 2, 2018 |
| Posted date | Oct 2, 2018 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b), 820, 803.50(a) |
| Inspection city | Spanga |
| Inspection start date | May 7, 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: