Warning letter
Power Medical Interventions Incorporation: warning letter of Oct 21, 2008
FDA warning letter 28006 · Philadelphia District Office
Key facts
| Reference number | 28006 |
|---|---|
| Company | Power Medical Interventions Incorporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Oct 21, 2008 |
| Posted date | Oct 21, 2008 |
| Issuing office | Philadelphia District Office |
| Product type | Devices |
| CFR sections cited | 803, 820, 803.50(a)(1), 803.50(a)(2), 803.50(b)(3) |
| Inspection city | Langhorne |
| Inspection ZIP | 19047-1810 |
| Inspection start date | Apr 7, 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: