Warning letter
Arjo Med. AB [ARCHIVED]: warning letter of Jun 10, 2009
FDA warning letter 58442 · Center for Devices and Radiological Health
Key facts
| Reference number | 58442 |
|---|---|
| Company | Arjo Med. AB [ARCHIVED] |
| Subject | CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated |
| Issue date | Jun 10, 2009 |
| Posted date | Jun 10, 2009 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 803.50(a)(1), 803.50(a)(2), 803.18, 820, 803.50(b)(3) |
| Inspection city | Gloucester |
| Inspection start date | Jan 12, 2009 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: