Warning letter
BioHorizons Implant Systems, Inc.: warning letter of Dec 27, 2004
FDA warning letter UCM146732 · New Orleans District Office
Key facts
| Reference number | UCM146732 |
|---|---|
| Company | BioHorizons Implant Systems, Inc. |
| Subject | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated |
| Issue date | Dec 27, 2004 |
| Posted date | Dec 27, 2004 |
| Issuing office | New Orleans District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Country | 3 |
| Inspection city | Hoover |
| Inspection ZIP | 35244-2808 |
| Inspection start date | Oct 26, 2004 |
| 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: