1243163
Lynch Biologics LLC — FEI 3011175224
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 2, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Franklin, TN (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |