FDA Inspection
Summit Medical, LLCSummit Medical, LLC – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns Summit Medical, LLC, with an inspection on March 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c5fd2a8a-d2f1-43d6-836e-71e74981f436
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045106
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Summit Medical, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 10, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 5, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 28, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Summit Medical, LLC
- FDA Inspection 1051976 - 2018-05-14
- FDA Inspection 992583 - 2016-11-10
- FDA Inspection 916770 - 2015-03-04
- FDA Inspection 878518 - 2014-05-05
- FDA Inspection 816910 - 2013-01-28
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