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Symbios Medical Products, LLC, Indianapolis, IN – FDA Inspections

Inspection records and compliance data for Symbios Medical Products, LLC in Indianapolis, Indiana. 5 FDA inspections on record (1 OAI), last inspected October 20, 2025.

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Company Profile

This profile covers Symbios Medical Products, LLC based in Indianapolis, Indiana, United States.

FDA Inspection History

FDA inspections
5
OAI
1
VAI
2
NAI
2
Form 483s
0
Warning letters
0

First inspected August 26, 2009. Last inspected October 20, 2025.

Most cited issue areas

  • Documentation2 inspections
  • Design validation- Lack of or inadequate procedures1 inspection
  • Design Validation - Risk analysis not performed/inadequate1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
October 20, 2025NAIMedical Devices & Rad Health · Compliance: Devices1289302
June 3, 2013OAIMedical Devices & Rad Health · Compliance: Devices834119
March 19, 2013NAIMedical Devices & Rad Health · Compliance: Devices822737
April 22, 2011VAIMedical Devices & Rad Health · Compliance: Devices722543
August 26, 2009VAIMedical Devices & Rad Health · Compliance: Devices604393
FDA documents

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

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Helio Genomics, Inc.
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Company Information

Name

Symbios Medical Products, LLC

FEI Number

3005203102

Address

7301 Georgetown Rd Ste 150, Indianapolis, Indiana 46268, United States

Country

United States

ID: 6faef43a-ddbb-4a37-ba99-c42af592912f

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