FY 2018 Manufacturer Audit Results

Updated 5/23/19. The results chart includes audits where the findings have been finalized. Remaining audits are still under review. Information on Corrective Action Plans and Sanctions will be updated once approved by HRSA. HRSA recommends covered entities do not contact audited manufacturers regarding sanctions until a corrective action plan has been approved by HRSA and posted on this website.

Results posted for 5 audits.

Manufacturer Labeler Codes Reviewed State OPA Findings Sanction Corrective Action Status Manufacturer Contact Information
Belcher Pharmaceuticals, LLC 62250 FL Belcher did not offer covered outpatient drugs to eligible covered entities at the statutory ceiling price. Repayment to covered entities CAP implemented

Audit closure date: May 8, 2019

General Counsel
Belcher Pharmaceuticals, LLC
O: (727) 471-0850, ext 789 F: (727) 471-0858
M: (813) 418-
9034
sst@belcherpharma.com
www.belcherpharma.com
Cumberland Pharmaceuticals, Inc. 66220 TN No adverse findings None N/A  
Horizon Pharma USA, Inc. 75987
42238
49663
76325
IL No adverse findings None N/A  
Johnson & Johnson Health Care Systems 00045
00062
50458
08004
62341
10147
16837
17314
56091
57894
59676
65847
68669
NJ No adverse findings None N/A  
Takeda Pharmaceuticals America, Inc. 64764 IL No adverse findings None N/A  
Date Last Reviewed:  May 2019