FDA Inspection
Affinity Biologicals Inc.Affinity Biologicals Inc. – FDA Inspection, Jun 11, 2015
Record Details
This FDA Inspection record concerns Affinity Biologicals Inc., with an inspection on June 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Affinity Biologicals Inc.
- Inspection Date
- June 11, 2015
- Product Type
- Devices
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ID · 6b81863f-2c7b-483e-ae7b-9ecbc975737b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 929304
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Affinity Biologicals Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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