FDA Inspection
Signal Medical CorporationSignal Medical Corporation – FDA Inspection, Nov 9, 2009
Record Details
This FDA Inspection record concerns Signal Medical Corporation, with an inspection on November 9, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Signal Medical Corporation
- Inspection Date
- November 9, 2009
- Product Type
- Devices
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ID · 9472baad-400c-41f3-909d-ab53d15198c8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 626882
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.184(d)Acceptance records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Signal Medical Corporation
9| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 27, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 2, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Signal Medical Corporation
- FDA Inspection 1202167 - 2023-04-10
- FDA Inspection 1000923 - 2017-02-03
- FDA Inspection 911283 - 2015-01-27
- FDA Inspection 890639 - 2014-08-11
- FDA Inspection 778457 - 2012-05-02
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