Warning letter
Volk Optical, Inc.: warning letter of Jul 7, 2008
FDA warning letter UCM1048217 · Cincinnati District Office
Key facts
| Reference number | UCM1048217 |
|---|---|
| Company | Volk Optical, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 7, 2008 |
| Posted date | Jul 7, 2008 |
| Issuing office | Cincinnati District Office |
| Product type | Devices |
| CFR sections cited | 806, 806.20(b)(4), 820 |
| Country | 3 |
| Inspection city | Mentor |
| Inspection ZIP | 44060-5309 |
| Inspection start date | Apr 29, 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: