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IO Orthopedic Systems LLC, Dallas, TX – FDA Inspections

Inspection records and compliance data for IO Orthopedic Systems LLC in Dallas, Texas. 1 FDA inspection on record, 1 Form 483, last inspected June 01, 2017.

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Company Profile

This profile covers IO Orthopedic Systems LLC based in Dallas, Texas, United States.

FDA Inspection History

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

Inspected June 1, 2017.

Most cited issue areas

  • Evaluation--microorganisms, damage1 inspection
  • Procedures to meet core CTGP1 inspection
  • Storage temperatures recorded, maintained1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
June 1, 2017VAIBiologics · Human Cellular, Tissue, and Gene Therapies1012343
FDA documents

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

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Company Information

Name

IO Orthopedic Systems LLC

FEI Number

3011706002

Address

8100 John W Carpenter Fwy Ste 210, Dallas, Texas 75247, United States

Country

United States

ID: b1da1ae1-4b41-44b6-88b5-3a02065cd9d0

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