FDA Inspection
Theralase Inc.Theralase Inc. – FDA Inspection, Nov 15, 2012
Record Details
This FDA Inspection record concerns Theralase Inc., with an inspection on November 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Theralase Inc.
- Inspection Date
- November 15, 2012
- Product Type
- Devices
View Company Profile
ID · f02ba8e4-fd2d-42ad-a422-b0e7ac7daada
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 809879
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 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 820.50(b)Supplier notification of changes
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