FDA Inspection
Peace Medical Inc.Peace Medical Inc. – FDA Inspection, Apr 5, 2011
Record Details
This FDA Inspection record concerns Peace Medical Inc., with an inspection on April 5, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Peace Medical Inc.
- Inspection Date
- April 5, 2011
- Product Type
- Devices
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ID · 9c4a33d7-4c94-42d7-9b7d-ebdf345901bc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 718221
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Peace Medical Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2025 | NAI | New Jersey District Office | Postmarket Assurance: Medical Devices |
| November 3, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 8, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 26, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Peace Medical Inc.
- FDA Inspection 1258337 - 2025-01-14
- FDA Inspection 1156667 - 2021-11-03
- FDA Inspection 1044569 - 2018-02-08
- FDA Inspection 745805 - 2011-09-26
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