# Premier Heart, LLC – FDA Inspection, Feb 8, 2018

Source: https://www.keypedia.com/records/fda_inspections/premier-heart-llc/8ea828ef-bfdc-49ee-9375-d9d7546a7f21
Source feed: FDA_Inspections

> FDA inspection 1040432 of Premier Heart, LLC, February 08, 2018. Classification: Voluntary Action Indicated (VAI). 3 citations under 21 CFR part 820. Form 483 issued. 5 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1040432
- Company Name: Premier Heart, LLC
- Inspection Date: 2018-02-08
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 3

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- FDA Inspection 931172 - 2015-06-11
- [FDA Inspection 822887 - 2013-03-15](https://www.keypedia.com/records/fda_inspections/premier-heart-llc/f6243ec7-f166-443e-ae63-58153b39aa50)
- [FDA Inspection 730081 - 2011-06-10](https://www.keypedia.com/records/fda_inspections/premier-heart-llc/e88dfefb-bc0e-49ee-9545-11efb89cf5bd)

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.keypedia.com/companies/premier-heart-llc/9bde989f-8561-4595-8aed-fe2272284c6a

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7