Inspections, Compliance, Enforcement, and Criminal Investigations
Application Integrity Policy List
The names of the firms listed below are those that were notified that FDA is deferring substantive scientific review of one or more of the firm's applications and/or is proceeding to withdraw the approved applications.
The asterisk (*) indicates that, to the agency's knowledge, the firm is out of business. This table includes the company's Central File Number and identification number in FDA's electronic Field Accomplishment and Compliance Tracking System (FACTS); or the FACTS Federal Establishment Identification Number (FEI).
CENTER FOR DRUG EVALUATION AND RESEARCH
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
CENTER FOR VETERINARY MEDICINE
10-07-2011 Added Hill Dermaceuticals, Inc., Sanford, FL, Consent Decree dated 9/27/2011.
07-13-2010 Removed Applied Biotech, Inc., San Diego, CA, Removal Letter dates 07/09/2010.
02-25-2009 Corrected spelling to "Paonta" in CDER section for location of Ranbaxy Labs.