FDA Inspection
Care Tech Industries, Inc.Care Tech Industries, Inc. – FDA Inspection, Jun 10, 2010
Record Details
This FDA Inspection record concerns Care Tech Industries, Inc., with an inspection on June 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Care Tech Industries, Inc.
- Inspection Date
- June 10, 2010
- Product Type
- Devices
View Company Profile
ID · 7b59b0fd-9e1e-461f-bde3-ec898bdfafa1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 666105
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
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