FDA Inspection
Summit Industries Inc.Summit Industries Inc. – FDA Inspection, May 29, 2012
Record Details
This FDA Inspection record concerns Summit Industries Inc., with an inspection on May 29, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Summit Industries Inc.
- Inspection Date
- May 29, 2012
- Product Type
- Devices
View Company Profile
ID · e2651b28-5831-4fea-b0a1-3adbc49242e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 787439
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Summit Industries Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2025 | NAI | Chicago District Office | Postmarket Assurance: Medical Devices |
| September 30, 2022 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 29, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 2, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 10, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Summit Industries Inc.
- FDA Inspection 1264391 - 2025-03-20
- FDA Inspection 1180911 - 2022-09-30
- FDA Inspection 1027765 - 2017-09-29
- FDA Inspection 838805 - 2013-07-02
- FDA Inspection 546595 - 2008-11-10
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