FY21 Manufacturer Audit Results

Updated 6/16/2022. 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
Akorn, Inc. 17478
49411
50383
61748		 IL
  1. Akorn did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund.
  2. Akorn did not submit quarterly pricing data to 340B OPAIS.
 Repayment to covered entities

CAP implemented

Audit closure date: April 26, 2022

 Chief Commercial Officer
847-582-6936
1925 West Field Court
Suite 300
Lake Forest, IL 60045
Jon.Kafer@akorn.com
BioComp Pharma 44523
00178		 TX

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

 Repayment to covered entities CAP approved Compliance Coordinator – Medicaid
210-581-0683
10999 IH 10 West, Suite 1000
San Antonio, TX 78230
Iliana.herrera@missonpharmacal.com
Chain Drug Marketing Association 63868 MI
  1. CDMA did not offer covered outpatient drugs to eligible covered entities at the statutory ceiling price.
  2. CDMA did not submit quarterly pricing data to 340B OPAIS.
 Repayment to covered entities CAP approved Medicaid Specialist
248-465-0670
W 9 Mile Road
Novi, MI 48375
donnan@chaindrug.com
Neos Therapeutics 70165
62542		 TX No adverse findings None

N/A

  
TAGI Pharma, Inc. 51224
68094		 IL
  1. Precision Dose charged more than the 340B ceiling price.
  2. Precision Dose did not determine the difference between new drug price estimates and actual 340B ceiling price and offer a refund.
  3. Tagi and Precision dose did not submit quarterly pricing data to 340B OPAIS.
 Repayment to covered entities

CAP implemented

Audit closure date: May 20, 2022

TAGI Pharma, Inc.:
Marketing Analyst
815-624-8523 ext.303
722 Progressive Lane, Room 205
South Beloit, IL 61080
dsundstrom@tagipharma.com

Precision Dose, Inc.:
Contracts/Marketing Representatvie
815-624-8523 ext. 238
722 Progressive Lane
South Beloit, IL 61080
dpseracino@precisiondose.com
Date Last Reviewed:  June 2022