inforMED
FEI 3025666291

Cumberland Biotherapeutics, Llc.

1565 Jackson Point Road, Sewanee, TN, US

MDR events0All time
Recalls0All time
Registered products1
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility

Registered product codes

1 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 3025666291.

FDA inspections

2 on file

  • Voluntary Action Indicated (VAI)Jun 27, 2024

    Compliance: Devices · Citations posted

  • No Action Indicated (NAI)Jun 27, 2024

    Postmarket Assurance: Devices · Citations posted

Inspection citations

3 on file

  • 21 CFR 820.20(a)Jun 27, 2024

    Quality policy and objectives

  • 21 CFR 820.50Jun 27, 2024

    Purchasing controls, Lack of or inadequate procedures

  • 21 CFR 820.100(a)Jun 27, 2024

    Lack of or inadequate 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.