Updated 6/28/2024. 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 |
|---|---|---|---|---|---|
American Health PackagingContact InformationVice President - Controller |
60687 62584 68001 68084 |
OH |
Incorrect 340B OPAIS record. AHP charged more than the 340B ceiling price. AHP did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund. AHP did not submit quarterly pricing data in 340B OPAIS. |
Repayment to covered entities |
CAP implemented Audit closure date: May 20, 2024 |
| Medefil, Inc. | 64253 | IL |
Incorrect 340B OPAIS record. Medefil charged more than the 340B ceiling price. |
Manufacturer self-terminated from 340B Program. Repayment to covered entities |
CAP required prior to reentry. Settlements with affected covered entities have not been finalized. Manufacturer will not be permitted to reenter the 340B Program until such time: 1) Manufacturer has finalized settlement with all affected covered entities, 2) Manufacturer has demonstrated current compliance with all 340B Program requirements, and 3) Manufacturer has attested that a HRSA-approved CAP has been fully implemented. Audit closure date: May 15, 2024 |
Nephron Pharmaceuticals Corp.Contact InformationContract Analyst |
00487 | SC |
Nephron charged more than the 340B ceiling price. Nephron did not offer covered outpatient drugs to eligible covered entities at the 340B ceiling price. |
Repayment to covered entities |
CAP implemented Audit closure date: April 29, 2024 |
Red Hill BiopharmaContact InformationChief Financial Officer |
57841 | NC |
Red Hill charged more than the 340B ceiling price. |
Repayment to covered entities |
CAP approved |
| Teva Pharmaceuticals, Inc. |
00480 00093 00172 00228 00472 00555 00575 00591 00703 16252 45963 50111 51285 51759 52544 55253 57844 59310 62037 63459 68546 |
NJ |
No adverse findings |
None |
N/A Audit closure date: November 8, 2023 |