inforMED
FEI 3015522042

Aunt Flow Corp

757 Garden Road Ste 205, Columbus, OH, US

MDR events0All time
Recalls0All time
Registered products2
Establishment typeRepackRepack or Relabel Medical Device

Registered product codes

2 product codes

Recent MDR events

0 on file

No MDR events on file for this firm name.

Recalls

0 on file

No recalls on file for this firm name.

Compliance history

Matched by FEI 3015522042.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)May 8, 2025

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)May 8, 2025

    Postmarket Assurance: Devices · Citations posted

Inspection citations

7 on file

  • 21 CFR 820.20(c)May 8, 2025

    Management review - Lack of or inadequate procedures

  • 21 CFR 820.22May 8, 2025

    Quality audits - Lack of or inadequate procedures

  • 21 CFR 820.25(b)May 8, 2025

    Training - Lack of or inadequate procedures

  • 21 CFR 820.30(a)May 8, 2025

    Design control - no procedures

  • 21 CFR 820.50(a)May 8, 2025

    Evaluation of suppliers, contractors, etc., requirements

  • 21 CFR 820.100(a)May 8, 2025

    Lack of or inadequate procedures

  • 21 CFR 820.198(a)May 8, 2025

    Lack of or inadequate complaint procedures

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.