FDA Inspection
Premier Heart, LLCPremier Heart, LLC – FDA Inspection, Feb 8, 2018
Record Details
This FDA Inspection record concerns Premier Heart, LLC, with an inspection on February 8, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8ea828ef-bfdc-49ee-9375-d9d7546a7f21
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040432
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.200(d)Service reports
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Other FDA inspections of Premier Heart, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 28, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 10, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Premier Heart, LLC
- FDA Inspection 1256892 - 2024-11-15
- FDA Inspection 1153701 - 2021-09-28
- FDA Inspection 931172 - 2015-06-11
- FDA Inspection 822887 - 2013-03-15
- FDA Inspection 730081 - 2011-06-10
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