FY 2019 Manufacturer Audit Results

Updated: 5/12/20. 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
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 Manager, Pricing and Contracts Administration
BenjaminFanelli@lupin.com
Cell: (443) 255-8799
Office: (732) 584-6788
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 Manager, Pricing and Contracts Administration
BenjaminFanelli@lupin.com
Cell: (443) 255-8799
Office: (732) 584-6788
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 President & CEO
121 Marketridge Drive, Suite B
Ridgeland, MS 39157
fmundy@sxpire.com
601-990-9497
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 Pending  

 

Date Last Reviewed:  May 2020