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 |
|---|---|---|
| Grimann S.A. de C.V. | 05/23/2022 |
Close Out Letter |
| ECI Pharmaceuticals,LLC | 2/3/2022 | Close Out Letter 03/16/2022 |
|
3/26/2021 |
Close Out Letter |
|
| NuCare Pharmaceuticals Inc | 9/26/2019 | |
|
10/29/2018 |
Close Out Letter |
|
|
10/29/2018 |
Close Out Letter |
|
|
6/12/2018 |
Close Out Letter |
|
|
12/5/2017 |
1/31/2018 |
|
|
6/5/2017 |
|
|
|
6/1/2017 |
7/5/2017 |
|
|
4/19/2017 |
4/27/2017 |
|
|
9/29/2016 |
|
|
|
3/23/2016 |
5/6/2016 |
|
|
3/31/2015 |
5/21/2015 |
|
|
3/31/2015 |
|