Warning letter
Biomed Devices Corporation (AKA: Medlens Innovations, Inc.) [ARCHIVED]: warning letter of Feb 2, 2009
FDA warning letter 46158 · Baltimore District Office
Key facts
| Reference number | 46158 |
|---|---|
| Company | Biomed Devices Corporation (AKA: Medlens Innovations, Inc.) [ARCHIVED] |
| Subject | CGMP/Quality System/Adulterated |
| Issue date | Feb 2, 2009 |
| Posted date | Feb 2, 2009 |
| Issuing office | Baltimore District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Front Royal |
| Inspection ZIP | 22630 |
| Inspection start date | Oct 23, 2008 |
| 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: