Updated 7/29/2024. 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 Sort descending | Labeler Codes Reviewed | State | OPA Findings | Sanction | Corrective Action Status |
|---|---|---|---|---|---|
| Amryt Pharmaceuticals, Inc. |
10122 69880 76431 |
NC |
No adverse findings |
None |
N/A Audit closure date: May 14, 2024 |
| Ascend Laboratories, LLC |
53097 67877 |
NJ |
No adverse findings |
None |
N/A Audit closure date: May 2, 2024 |
| Asegua Therapeutics, LLC |
15584 55135 61958 71287 72626 |
CA |
No adverse findings |
None |
N/A Audit closure date: May 15, 2024 |
| B. Braun Medical, Inc. | 264 | PA |
B. Braun charged more than the 340B ceiling price. B. Braun did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund. |
Repayment to covered entities |
Pending |
| Sun Pharmaceutical Industries, Inc. |
47335 10631 41616 49708 51660 51672 53489 57664 62756 63304 67308 70095 |
NY |
Incorrect 340B OPAIS record - Incorrect entry in 340B OPAIS for Authorizing Official and Primary Contact information, manufacturer name, and labeler codes and addresses. Sun charged more than the 340B ceiling price. Sun did not determine the difference between new drug price estimates and actual 340B ceiling prices and offer a refund. Sun failed to refund covered entities for charges that were more than the 340B ceiling price. Sun did not submit quarterly pricing to 340B OPAIS pricing component. |
Repayment to covered entities |
Pending |