Branan Medical Gets Closeout Letter Resolving Clearance Concerns

Branan Medical, a maker of drug testing kits, received an FDA closeout letter resolving myriad marketing clearance and manufacturing concerns cited in a 2009 warning letter. Corrective action taken by Branan in response to the agency’s Dec. 28, 2009, warning letter “appears” to have resolved the company’s lack of an approved PMA application or IDE application noted at the time, the FDA said in a recently posted closeout letter. Branan was cited for a slew of manufacturing deficiencies in the 11-observation letter, including failure to establish adequate procures for product stability testing and staff training.
Devices & Diagnostics Letter