Warning letter
BioGenex Laboratories: warning letter of Jul 27, 2006
FDA warning letter UCM076009 · San Francisco District Office
Key facts
| Reference number | UCM076009 |
|---|---|
| Company | BioGenex Laboratories |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Jul 27, 2006 |
| Posted date | Jul 27, 2006 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Country | 3 |
| Inspection city | Fremont |
| Inspection ZIP | 94538-7301 |
| Inspection start date | Feb 1, 2006 |
| 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: