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•United States

Backjoy Orthotics LLC, Boulder, CO – FDA Inspections

Inspection records and compliance data for Backjoy Orthotics LLC in Boulder, Colorado. 1 FDA inspection on record, 1 Form 483, last inspected March 07, 2017.

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Company Profile

This profile covers Backjoy Orthotics LLC based in Boulder, Colorado, United States.

FDA Inspection History

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

Inspected March 7, 2017.

Most cited issue areas

  • Lack of or inadequate complaint procedures1 inspection
  • Lack of Written MDR Procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
March 7, 2017VAIMedical Devices & Rad Health · Compliance: Devices1005610
FDA documents

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

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Carroll, John D.
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J.Alex Sielatycki, M.D.
Shah, Raj J., MD
Company Information

Name

Backjoy Orthotics LLC

FEI Number

3007279921

Address

6685 Gunpark Dr Ste 200, Boulder, Colorado 80301, United States

Country

United States

ID: 452c76d1-642a-4b39-ba7e-cf251faa2df3

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