Warning letter
Diopsys, Inc.: warning letter of Feb 1, 2005
FDA warning letter UCM075268 · New Jersey District Office
Key facts
| Reference number | UCM075268 |
|---|---|
| Company | Diopsys, Inc. |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Feb 1, 2005 |
| Posted date | Feb 1, 2005 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 807.81(a)(3)(i), 820, 807.81(b) |
| Country | 3 |
| Inspection city | Pine Brook |
| Inspection ZIP | 07058-8900 |
| Inspection start date | Aug 18, 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: