FDA Inspection
Antibodies IncAntibodies Inc – FDA Inspection, Mar 21, 2012
Record Details
This FDA Inspection record concerns Antibodies Inc, with an inspection on March 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Antibodies Inc
- Inspection Date
- March 21, 2012
- Product Type
- Devices
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ID · fd9f33c4-5fd0-474a-99dd-10cbae59a9f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774844
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Antibodies Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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