FDA Inspection
Premier Heart, LLCPremier Heart, LLC – FDA Inspection, Jun 10, 2011
Record Details
This FDA Inspection record concerns Premier Heart, LLC, with an inspection on June 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Premier Heart, LLC
- Inspection Date
- June 10, 2011
- Product Type
- Devices
View Company Profile
ID · e88dfefb-bc0e-49ee-9545-11efb89cf5bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730081
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.40(b)Change records, content
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(i)Documentation of software validation
Full citation text and observation details available on the Dashboard.
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 |
| February 8, 2018 | VAI | 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 |
Other documents for Premier Heart, LLC
- FDA Inspection 1256892 - 2024-11-15
- FDA Inspection 1153701 - 2021-09-28
- FDA Inspection 1040432 - 2018-02-08
- FDA Inspection 931172 - 2015-06-11
- FDA Inspection 822887 - 2013-03-15
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