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 |
|---|---|---|
| Shenzhen Hengkaifeng Commerce and Trade Co., Ltd | 5/6/2025 | A closing date will be added if/when the warning letter is closed out. |
| Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC | 3/28/2025 | Close Out Letter 5/19/2025 |
| Media Networks Sydney Pty Limited | 8/15/2024 | Close Out Letter 9/18/2024 |
| 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 | Close Out Letter 9/11/2024 |
| 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. |