FDA Inspection
JointHeat, Inc.JointHeat, Inc. – FDA Inspection, Jun 6, 2011
Record Details
This FDA Inspection record concerns JointHeat, Inc., with an inspection on June 6, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- JointHeat, Inc.
- Inspection Date
- June 6, 2011
- Product Type
- Devices
View Company Profile
ID · 78787a53-2406-4a3a-8a38-e7eda807142a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 728045
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.50(b)Supplier notification of changes
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