FDA Inspection 762064 — Edermy LLC
The FDA completed an inspection of Edermy LLC on Dec 27, 2011 in Pendergrass, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 27, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pendergrass, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |