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  5. Electronic Registration and Listing Compliance Program
  1. Electronic Drug Registration and Listing System (eDRLS)

Electronic Registration and Listing Compliance Program

Accuracy and integrity of establishment registration and drug listing data are essential to FDA’s mission. Several key programs inside and outside the agency such as inspections, commercial drug databases, electronic prescribing and reimbursement rely upon registration and listing information.

FDA employs automated validation rules in order to prevent inaccurate and incomplete data submission; however, not all the data screening can be automated. Our compliance program is designed to monitor the registration and listing data through surveillance methods, have manufacturers correct any data inaccuracies and ultimately remove inaccurate data from the public sites, if corrections are not made as required. Certain violations of federal law can result in further actions such as data inactivation and/or a warning letter.

Please contact eDRLS@fda.hhs.gov if you have questions about FDA’s registration and listing compliance program or any published registration or listing data.

FDA issued the following warning letters:

Warning Letter/Company

 Issue Date

 Closeout Date

RPK Pharmaceuticals Inc.

 3/26/2021

 

Netcos Co., Ltd.

 10/29/2018

Close Out Letter
11/30/2018

United Exchange Corporation

 10/29/2018

Close Out Letter
11/30/2018

AMI Cosmetic Co., Ltd. 

 6/12/2018

 Close Out Letter 
 7/11/2018  

Aphena Pharma Solutions-Tennessee, LLC

 12/5/2017

 1/31/2018

A-S Medication Solutions LLC.

 6/5/2017

 

Prestige Brands Holdings

 6/1/2017

 7/5/2017

Exact-Rx Inc

 4/19/2017

 4/27/2017

Targeted Medical Pharma, Inc. dba Physician Therapeutics

 10/6/2016

 

Wallace Cameron International Ltd

 9/29/2016

 

Pharmaceutical Associates Inc

 3/23/2016

 5/6/2016

RemedyRepack Inc.

 3/31/2015

 5/21/2015

Rebel Distributors Corp

 3/31/2015

 

Additional Resources

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