FDA Inspection
ApiFix, Ltd.ApiFix, Ltd. – FDA Inspection, Jun 6, 2019
Record Details
This FDA Inspection record concerns ApiFix, Ltd., with an inspection on June 6, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eaeebd11-0f20-4813-9596-517fb7ee156a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092360
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(e)Documentation
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