FY 2017 Manufacturer Audit Results

Updated 7/24/25. 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 Sort descending Labeler Codes Reviewed State OPA Findings Sanction Corrective Action Status
Biogen U.S. Corp. 59627
64406
MA

No adverse findings

None

N/A

Audit closure date: November 2, 2017

EMD Serono, Inc. 44087 MA No adverse findings

None

N/A

Audit closure date: November 2, 2017

Jacksonville Pharmaceuticals, Inc. 70003 FL No adverse findings

None

N/A

Audit closure date: July 25, 2017

Pharmacyclics, LLC 57962 CA No adverse findings

None

N/A

Audit closure date: November 21, 2017

Shire US, Inc. 42227
47783
59417
54092
58521
66593
68875
64193
00944
PA

No adverse findings

None

N/A

Audit closure date: July 28, 2017

Date Last Reviewed: