The FDA cited Debut Development for inadequate quality and water system procedures at its Wauchula, Florida OTC drugmaking facility.
In a Sept. 17-20, 2018 inspection, the agency investigator found that the firm lacked written procedures or designated personnel to handle quality responsibilities. The lack of a quality unit “resulted in no change control system, no supplier qualification program, no approval of laboratory investigations, and other quality functions,” according to the Form 483.
The firm lacked investigation reports for any out of specification test results. For example, in July 2018, the facility received failing results for a microbial test performed on the water system. Although staff recalled additional in-house testing, the test results log showed no subsequent tests were performed.