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  4. FY 2020 Manufacturer Audit Results

FY 2020 Manufacturer Audit Results

Updated: 9/22/21. 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 Sort descending Labeler Codes Reviewed State OPA Findings Sanction Corrective Action Status
Eisai, Inc. 62856 NJ

No adverse findings

None

N/A

Indivior Incorporated 12496 VA

No adverse findings

None

N/A

Kyowa Kirin, Inc. 42747 NJ

No adverse findings

None

N/A

Pharmaceutical Associates, Inc.
Contact Information

Labeler 00121:
Chargeback Systems Manager
patfowler@paipharma.com
864-277-7282 x3382

Labeler 00486:
Controller
Nanderson@beachpharma.com
813-839-6565 x202

00121
00486
SC

1. Incorrect 340B OPAIS record

2. PAI charged more than the 340B ceiling price

Repayment to covered entities

CAP implemented

Audit closure date: June 23, 2021

Westminster Pharmaceuticals, LLC
Contact Information

Contract Specialist
1-888-354-9939 ext. 1019

69367 TN

1. Westminster charged more than the 340B ceiling price.

2. Westminster did not offer covered outpatient drugs to eligible covered entities at the statutory ceiling price.

3. Westminster did not submit quarterly pricing data to 340B OPAIS.

Repayment to covered entities

CAP implemented

Audit closure date: June 9, 2021

Date Last Reviewed: