Warning letter
Shelhigh, Inc.: warning letter of Dec 14, 2005
FDA warning letter UCM075736 · New Jersey District Office
Key facts
| Reference number | UCM075736 |
|---|---|
| Company | Shelhigh, Inc. |
| Subject | CGMP Requirement for Medical Devices/Lacks Premarket Approval Application/Adulterated |
| Issue date | Dec 14, 2005 |
| Posted date | Dec 14, 2005 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 806, 814, 814.108, 814.126, 812, 803.18(b), 820, 806.10(a), 814.124(a), 821.25(a) and 1 more |
| Country | 3 |
| Inspection city | Union |
| Inspection ZIP | 07083-8130 |
| Inspection start date | Jul 21, 2005 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: