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.
| Manufacturer | Labeler Codes Reviewed | State | OPA Findings | Sanction | Corrective Action Status Sort descending |
|---|---|---|---|---|---|
Pharmaceutical Associates, Inc.Contact InformationLabeler 00121: Labeler 00486: |
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 |
Westminster Pharmaceuticals, LLCContact InformationContract Specialist |
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 |
| 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 |