FDA Inspection
Froncare IncFroncare Inc – FDA Inspection, Nov 7, 2018
Record Details
This FDA Inspection record concerns Froncare Inc, with an inspection on November 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d074b603-5231-45d6-ad40-4e7f06c02a3a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1071496
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Froncare Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 28, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Froncare Inc
- FDA Inspection 1229775 - 2024-02-07
- FDA Inspection 1121717 - 2020-02-28
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