FDA Inspection
Focal Healthcare Inc.Focal Healthcare Inc. – FDA Inspection, May 24, 2017
Record Details
This FDA Inspection record concerns Focal Healthcare Inc., with an inspection on May 24, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · bdb2441f-c1af-4e0a-9b21-299640077147
Inspection Facts
- Inspection number
- 1012058
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Focal Healthcare Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2018 | Not classified | Office of Inspections and Investigations |
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