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•United States

Innovasis, Inc, Salt Lake City, UT – FDA Inspections

Inspection records and compliance data for Innovasis, Inc in Salt Lake City, Utah. 5 FDA inspections on record, last inspected August 20, 2019.

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Company Profile

This profile covers Innovasis, Inc based in Salt Lake City, Utah, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
2
NAI
3
Form 483s
0
Warning letters
0

First inspected June 26, 2009. Last inspected August 20, 2019.

Most cited issue areas

  • Acceptance criteria and essential outputs1 inspection
  • Analysis of data/reports from data sources1 inspection
  • Design changes - Lack of or Inadequate Procedures1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
August 20, 2019NAIBiologics · Human Cellular, Tissue, and Gene Therapies1102677
June 22, 2016NAIBiologics, Medical Devices & Rad Health · Postmarket Assurance: Devices979759
May 22, 2014NAIBiologics · Human Cellular, Tissue, and Gene Therapies879760
April 27, 2012VAIBiologics, Medical Devices & Rad Health · Compliance: Devices778886
June 26, 2009VAIMedical Devices & Rad Health · Compliance: Devices594578
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Transcoject GmbH
K2M, Inc.
Millstone Medical Outsourcing, LLC
Choice Spine LLC
BioHorizons Implant Systems Inc
Company Information

Name

Innovasis, Inc

FEI Number

3004719693

Address

614 E 3900 S, Salt Lake City, Utah 84107, United States

Country

United States

ID: b5d5d0ea-ada5-4bed-a02d-e82565aaa165

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