FDA Inspection 1056954 — Affinity Biologicals Inc.
The FDA completed an inspection of Affinity Biologicals Inc. on Jun 14, 2018 in Ancaster. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ancaster (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |