FDA Inspection
Bio Protech Yantai Inc.Bio Protech Yantai Inc. – FDA Inspection, Mar 13, 2025
Record Details
This FDA Inspection record concerns Bio Protech Yantai Inc., with an inspection on March 13, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 6162f3b0-e381-49c5-ab1f-b0ad4e374814
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1264478
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.86Acceptance status
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Other FDA inspections of Bio Protech Yantai Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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