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 provisions for nonconforming components.