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  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/CompanyIssue DateCloseout Date
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd5/6/2025A closing date will be added if/when the warning letter is closed out.
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC3/28/2025Close Out Letter
5/19/2025
Media Networks Sydney Pty Limited8/15/2024Close Out Letter
9/18/2024
Dr Sankunni’s Ayurvedic Research Foundation Private Ltd. 4/18/2024A closing date will be added if/when the warning letter is closed out.
Zen Enterprises LLC4/18/2024Close Out Letter
9/11/2024
Ehy Holdings, LLC2/02/2024A closing date will be added if/when the warning letter is closed out.
Walgreen Company9/12/2023A closing date will be added if/when the warning letter is closed out.
Lydia Co Ltd.6/26/2023Close Out Letter
8/18/2023
Procter & Gamble Manufactura S. de R.L. de C.V.3/14/2023Close Out Letter
03/27/2023
The Body Bean, LLC2/06/2023A closing date will be added if/when the warning letter is closed out.
Unit Dose Services, LLC10/19/2022Close Out Letter 
12/21/2022
RiteAid Corporation10/17/2022Close Out Letter
12/20/2022
Grimann S.A. de C.V.5/23/2022Close Out Letter
06/03/2022
ECI Pharmaceuticals,LLC2/03/2022Close Out Letter
03/16/2022
RPK Pharmaceuticals Inc.3/26/2021Close Out Letter
06/01/2021
NuCare Pharmaceuticals Inc9/26/2019A closing date will be added if/when the warning letter is closed out.
Netcos Co., Ltd.10/29/2018Close Out Letter
11/30/2018
United Exchange Corporation10/29/2018Close Out Letter
11/30/2018
AMI Cosmetic Co., Ltd. 6/12/2018Close Out Letter 
7/11/2018
Aphena Pharma Solutions-Tennessee, LLC12/5/20171/31/2018
A-S Medication Solutions LLC.6/05/2017A closing date will be added if/when the warning letter is closed out.
Prestige Brands Holdings6/01/20177/5/2017
Exact-Rx Inc4/19/20174/27/2017
Wallace Cameron International Ltd9/29/2016A closing date will be added if/when the warning letter is closed out.
Pharmaceutical Associates Inc3/23/20165/6/2016
Remedy Repack Inc.3/31/20155/21/2015
Rebel Distributors Corp3/31/2015A closing date will be added if/when the warning letter is closed out.

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