Updated: 3/19/21. 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 Sort descending | Labeler Codes Reviewed | State | OPA Findings | Sanction | Corrective Action Status |
|---|---|---|---|---|---|
Gavis Pharmaceuticals, LLCContact InformationManager, Pricing and Contracts Administration |
43386 | NJ |
1. Incorrect 340B OPAIS record |
Repayment to covered entities |
CAP approved Audit closure date: September 10, 2020 |
| Kedrion Biopharma Inc. |
76179 76125 00562 |
NJ |
No adverse findings |
None |
N/A |
Lupin Pharmaceuticals, Inc.Contact InformationManager, Pricing and Contracts Administration |
68180 27437 |
MD |
1. Incorrect 340B OPAIS record 2. Lupin charged more than the 340B ceiling price 3. Lupin did not submit quarterly pricing data to 340B OPAIS |
Repayment to covered entities |
CAP approved Audit closure date: September 10, 2020 |
Paddock LaboratoriesContact InformationMedicaid Finance Representative |
00574 45802 00113 |
MI |
Labeler 00113 did not offer covered outpatient drugs to eligible covered entities at the statutory ceiling price |
Repayment to covered entities |
CAP Approved Audit closure date: |
Xspire PharmaContact InformationPresident & CEO |
42195 | MS |
Xspire did not offer covered outpatient drugs to eligible covered entities at the statutory ceiling price |
Repayment to covered entities |
CAP approved Audit closure date: November 30, 2020 |