FDA Inspection 585780 — Facet Technologies, LLC
The FDA completed an inspection of Facet Technologies, LLC on April 7, 2009 in Atlanta, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 7, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 540 | 21 CFR 820.70(b) | Production and process changes - failure to follow procedure |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |