FY20 Manufacturer Audits Results

Updated: 9/22/21. 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
Eisai, Inc. 62856 NJ No adverse findings None N/A  
Indivior Incorporated 12496 VA No adverse findings None

N/A

  
Kyowa Kirin, Inc. 42747 NJ No adverse findings None N/A  
Pharmaceutical Associates, Inc. 00121,
00486		 SC
  1. Incorrect 340B OPAIS record
  2. PAI charged more than the 340B ceiling price
 Repayment to covered entities CAP implemented

Audit closure date: June 23, 2021

 Labeler 00121:
Chargeback Systems Manager
patfowler@paipharma.com
864-277-7282 x3382

Labeler 00486:
Controller
Nanderson@beachpharma.com
813-839-6565 x202
Westminster Pharmaceuticals, LLC 69367 TN
  1. Westminster charged more than the 340B ceiling price.
  2. Westminster did not offer covered outpatient drugs to eligible covered entities at the statutory ceiling price.
  3. Westminster did not submit quarterly pricing data to 340B OPAIS.
 Repayment to covered entities

CAP implemented

Audit closure date: June 9, 2021

 Contract Specialist
1-888-354-9939 ext. 1019
Date Last Reviewed:  September 2021