FDA Inspection
PerioSeal, Inc.PerioSeal, Inc. – FDA Inspection, Aug 9, 2012
Record Details
This FDA Inspection record concerns PerioSeal, Inc., with an inspection on August 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- PerioSeal, Inc.
- Inspection Date
- August 9, 2012
- Product Type
- Devices
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ID · eed3b792-408a-4045-bb5f-e225c0891569
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 794886
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of PerioSeal, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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