Warning letter
PhotoMedex, Inc.: warning letter of Jan 26, 2012
FDA warning letter 225674 · Philadelphia District Office
Key facts
| Reference number | 225674 |
|---|---|
| Company | PhotoMedex, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 26, 2012 |
| Posted date | Jan 26, 2012 |
| Issuing office | Philadelphia District Office |
| Product type | Devices |
| CFR sections cited | 820, 803, 803.17, 807.81, 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b), 807.81(b) |
| Inspection city | Horsham |
| Inspection ZIP | 19044 |
| Inspection start date | Aug 1, 2011 |
| 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: