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.
Results posted for 5 audits.
Manufacturer | Labeler Codes Reviewed | State | OPA Findings | Sanction | Corrective Action Status | Manufacturer Contact Information |
---|---|---|---|---|---|---|
Gavis Pharmaceuticals, LLC | 43386 | NJ | 1. Incorrect 340B OPAIS record 2. Gavis charged more than the 340B ceiling price 3. Gavis did not submit quarterly pricing data to 340B OPAIS |
Repayment to covered entities | CAP approved Audit closure date: September 10, 2020 |
Manager, Pricing and Contracts Administration BenjaminFanelli@lupin.com Cell: (443) 255-8799 Office: (732) 584-6788 |
Kedrion Biopharma Inc. | 76179 76125 00562 |
NJ | No adverse findings | None | N/A |
|
Lupin Pharmaceuticals, Inc. | 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 |
Manager, Pricing and Contracts Administration BenjaminFanelli@lupin.com Cell: (443) 255-8799 Office: (732) 584-6788 |
Paddock Laboratories | 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: |
Medicaid Finance Representative 269-686-7218 490 N. Eastern Ave. Allegan, MI 49010 RSchuite@perrigo.com |
Xspire Pharma | 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 |
President & CEO 121 Marketridge Drive, Suite B Ridgeland, MS 39157 fmundy@xspirerx.com 601-990-9497 |