Did you know that 503B Outsourcing Facilities are tracked under CDER Strategic Area 2 – Drug Quality and Compliance on the CDER Dashboard.

Section III identifies Inspections and Enforcement of Compounders.  This CDER Dashboard identifies by fiscal year the number of compounds that recalled products, the number of warning letters issued, the number of state referral letters, the number of injuctions/consent decrees, and the total number of regestered outsoursing facilities.  The data is as current as shown of each of the individual webpages. However, there is a disclamer that The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

As with most FDA pages citizens can subscribe to the FDA-TRACK pages for updates and be informed via email when these pages are changed.

Here is an example of the graphic of warning letters issued to compounders in FY 2017:

The dashboard also tracks:
Strategic Area 1: Regulatory Review and Drug Safety
Stragegic Area 3: Tranaparency and Public Outreach
Stategic Area 4: Regulatory Science and Research

Have a question about cGMP compliance for 503B Outsourcing Facilities, please contact Rick Van Doel, PhD, or use our Contact Us form and we will respond shortly.

About Performance Validation:  Performance Validation is a 100% employee-owned company has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.