FDA Inspection
Pyng Medical CorporationPyng Medical Corporation – FDA Inspection, Dec 11, 2008
Record Details
This FDA Inspection record concerns Pyng Medical Corporation, with an inspection on December 11, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pyng Medical Corporation
- Inspection Date
- December 11, 2008
- Product Type
- Devices
View Company Profile
ID · a3e4f05a-6ecd-42e9-8c24-bd7e46976d01
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 565302
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(b)Procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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