Warning letter
Rhytec, Inc.: warning letter of Apr 24, 2007
FDA warning letter UCM076365 · New England District Office
Key facts
| Reference number | UCM076365 |
|---|---|
| Company | Rhytec, Inc. |
| Subject | CGMP for Medical Devices/QSR/Adulterated/Misbranded |
| Issue date | Apr 24, 2007 |
| Posted date | Apr 24, 2007 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 803, 806, 803.17(a)(2), 803.50(a)(1), 806.20(b)(4), 820, 803.50(b)(3) |
| Country | 3 |
| Inspection city | Waltham |
| Inspection ZIP | 02453-8901 |
| Inspection start date | Dec 13, 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: