FDA Inspection
First Call, Inc.First Call, Inc. – FDA Inspection, Jul 19, 2019
Record Details
This FDA Inspection record concerns First Call, Inc., with an inspection on July 19, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 48df3c18-73e8-44b7-9eb8-77b625ebf6a3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1097456
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184(f)DHR - UDI not included
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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