FDA Inspection
Affinity Biologicals Inc.Affinity Biologicals Inc. – FDA Inspection, Jun 14, 2018
Record Details
This FDA Inspection record concerns Affinity Biologicals Inc., with an inspection on June 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a557ed0b-e219-49e6-8b74-ea3396cb8897
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056954
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Affinity Biologicals Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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