FDA Inspection
Summit Medical, LLCSummit Medical, LLC – FDA Inspection, May 14, 2018
Record Details
This FDA Inspection record concerns Summit Medical, LLC, with an inspection on May 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e23c25df-2247-4f80-b6bc-fcc6637f933a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1051976
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Equipment suitability & capability
- 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 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Summit Medical, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2018 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| 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 1045106 - 2018-03-09
- 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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