FDA Inspection
Conductive Technologies, IncConductive Technologies, Inc – FDA Inspection, Mar 12, 2014
Record Details
This FDA Inspection record concerns Conductive Technologies, Inc, with an inspection on March 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Conductive Technologies, Inc
- Inspection Date
- March 12, 2014
- Product Type
- Devices
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ID · ff227adb-581f-4f92-939c-035445e0bc2a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 870655
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Showing 10 of 16 citations.
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Other FDA inspections of Conductive Technologies, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Conductive Technologies, Inc
- FDA Inspection 1180266 - 2022-08-26
- FDA Inspection 924941 - 2015-04-23
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