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  4. FY 2022 Manufacturer Audit Results

FY 2022 Manufacturer Audit Results

Updated 9/12/2023. 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 Sort descending Corrective Action Status
Mitsubishi Tanabe Pharma America, Inc. 70510 NJ

No adverse findings

None

N/A

Almaject Inc. 72611
47781
52427
43199
49909
13913
NJ

Almaject did not submit quarterly pricing data in 340B OPAIS

None

CAP implemented

Audit closure date: October 27, 2022

Unichem Pharmaceuticals (USA), Inc.
Contact Information

Prescription Analytics, Inc.
Attn: Matthew Erickson
121 S. Wilson Ave.
Hartford, WI 53027
rebates@prescriptionanalytics.com
262-292-6256

29300 NJ

Incorrect 340B OPAIS record.

Unichem did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund.

Repayment to covered entities

CAP implemented

Audit closure date: November 17, 2022

Vistapharm, Inc.
Contact Information

Finance Manager
Attn: Stacy Fletcher
Stacy.Fletcher@verticepharma.com

66689 NJ

Incorrect 340B OPAIS record.

Vistapharm charged more than the 340B ceiling price.

Repayment to covered entities

CAP implemented

Audit closure date: August 21, 2023

KVK-Tech, Inc.
Contact Information

Sr. Manager Customer Service/Accounting
110 Terry Drive
Newtown, PA 18940
sdicroce@kvktech.com
215-579-1842

10702 PA

Incorrect 340B OPAIS record

KVK-Tech failed to refund covered entities for charges that were more than the 340B ceiling price.

Repayment to covered entities

CAP implemented

Audit closure date:
July 12, 2023

Date Last Reviewed: