B. Braun Medical Inc.


Industry: Health Care
Underlying Misconduct: Federal Food, Drug, and Cosmetic Act
Matter Type: DOJ Criminal
Relevant Jurisdiction(s): Eastern District of North Carolina
Penalties: Fine, Restitution, Settlement Payment
Fine Amount: $1,000,000
Reporting Agencies: USAO Eastern District of North Carolina
Resolution Form: Non-Prosecution Agreement
Agreement Date: May 16, 2016
Monitor Reference Term: Independent Auditor/Reviewer
Monitor Identity: Unknown
Monitorship Term: 30 Months
Monitor Selection Process:

None noted in NPA; however, as it is DOJ, would presume DOJ Policy. For these reasons, some of the following entry areas could not be completed.

Time to Propose Monitors: N/A
Time to Engage Monitor: N/A
Time to First Report: 90 days
Reporting Frequency: Annually
Monitor Required Qualifications:

None specified.

Summary of Monitor's Scope:

Audit and assess Host Organization's compliance with the commitments to implement and maintain policies and procedures per Agreement.

Summary of Monitor's Activities:

Evaluate the effectiveness of internal controls, record-keeping, and policies and procedures as they relate to Host Organization's Type II PFG Quality Compliance Program, and take such reasonable steps as, in the Monitor's view, may be necessary to fulfill the Agreement mandate. Audit will include inspection of relevant docs, on-site observations (including internal controls, record-keeping, and quality procedures), meetings and interviews.

Monitor's Restrictions:

None specified; however, DOJ Policy generally requires that the Monitor not do any business with the Host Organization for a period of at least one year after the expiration of the Monitorship.

Documents Uploaded: B.Braun-Medical-NPA-DOJ-16May2016.pdf