646620
Acuderm, Inc. — FEI 1035236
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 19, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Ft Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 537 | 21 CFR 820.70(a) | Production processes |