The FDA hit Aqua Sciences with a Form 483 after discovering problems with its CAPA and quality audit procedures.
FDA investigators issued the form after a March inspection of the devicemaker’s Tonawanda, New York facility. FDA officials found the firm’s CAPA procedures did not contain enough detail to ensure they were effective and did not adversely affect the finished device. Several deviation reports the agency reviewed simply promised that “greater effort will be made to prevent this from happening in the future.”
The FDA also found no internal audits had been performed at the facility since 2013 and that the company’s nonconforming material procedures only included provisions for devices undergoing final testing or include provisions for nonconforming components. The company also lacked adequate process control procedures for assuring conformance.
The facility had no device history records for granular activated carbon tanks for manufacturing new deionization tanks or procedures, according to the 483. The company’s written medical device record procedure had no internal system providing for standardized review processes to determine when an event should be reported.
FDA officials also found no routine documentation of maintenance and repair or a documented supplier evaluation for the firm’s suppliers for resin, activated carbon or tanks, and several complaint records lacked a documented investigation.