inforMED
FEI 3015522042Initial importer

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.