FDA Inspection
GPC Medical Ltd.GPC Medical Ltd. – FDA Inspection, Jun 22, 2017
Record Details
This FDA Inspection record concerns GPC Medical Ltd., with an inspection on June 22, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · c59d83ea-5605-4d8d-94ea-ac9f5cf57cd8
Inspection Facts
- Inspection number
- 1015651
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of GPC Medical Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2019 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 3, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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