FDA Inspection
Therametric Technologies, Inc.Therametric Technologies, Inc. – FDA Inspection, Sep 11, 2014
Record Details
This FDA Inspection record concerns Therametric Technologies, Inc., with an inspection on September 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 11, 2014
- Product Type
- Devices
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ID · dd691484-4467-431f-805f-6583c7e5fae4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 897176
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
14- 21 CFR 820.40Procedures not adequately established or maintained
- 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(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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