FDA Cites Quasar Bio-Tech for Design Changes, Complaints
The FDA rapped Quasar Bio-Tech for inadequate design changes, complaint-handling and risk analysis in a Form 483 after an April 2018 inspection of the company’s Sarasota, Florida, facility.
Investigators found the company did not properly document design changes to product labeling to its Baby Quasar Plus and Quasar MD Plus, and the changes were not verified or validated for regulatory impact as required by the company’s written procedures.
The inspection also found a complaint received in October 2016 and internally identified as an adverse reaction was not properly investigated for MDR reportability. The customer in question said use of the device caused them to follow up with a “specialist,” but the company kept no records of follow-up with the customer to determine whether medical intervention was necessary.