U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Electronic Drug Registration and Listing System (eDRLS)
  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
Dr Sankunni’s Ayurvedic Research Foundation Private Ltd.  4/18/2024 A closing date will be added if/when the warning letter is closed out.
Zen Enterprises LLC 4/18/2024 A closing date will be added if/when the warning letter is closed out.
Ehy Holdings, LLC 2/02/2024

A closing date will be added if/when the warning letter is closed out.

Walgreen Company 9/12/2023 A closing date will be added if/when the warning letter is closed out.

Lydia Co Ltd.

6/26/2023

Close Out Letter
8/18/2023

Procter & Gamble Manufactura S. de R.L. de C.V. 3/14/2023 Close Out Letter
03/27/2023
The Body Bean, LLC 2/06/2023 A closing date will be added if/when the warning letter is closed out.
Unit Dose Services, LLC 10/19/2022 Close Out Letter 
12/21/2022
RiteAid Corporation 10/17/2022 Close Out Letter
12/20/2022
Grimann S.A. de C.V. 5/23/2022

Close Out Letter
06/03/2022

ECI Pharmaceuticals,LLC 2/03/2022 Close Out Letter
03/16/2022

RPK Pharmaceuticals Inc.

3/26/2021 Close Out Letter
06/01/2021
NuCare Pharmaceuticals Inc 9/26/2019 A closing date will be added if/when the warning letter is closed out.

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.

6/05/2017

A closing date will be added if/when the warning letter is closed out.

Prestige Brands Holdings

6/01/2017

7/5/2017

Exact-Rx Inc

4/19/2017

4/27/2017

Wallace Cameron International Ltd

9/29/2016

A closing date will be added if/when the warning letter is closed out.

Pharmaceutical Associates Inc

3/23/2016

5/6/2016

Remedy Repack Inc.

3/31/2015

5/21/2015

Rebel Distributors Corp

3/31/2015

A closing date will be added if/when the warning letter is closed out.

Additional Resources

 
Back to Top