During an inspection of the Medical Acoustics facility in Clarence, NY facility in December 2017, FDA investigators found that the firm failed to properly implement CAPA procedures.
Moreover, of 11 CAPAs the agency reviewed, at least five were not completed in a timely manner.
For example, an investigation opened Nov. 18, 2013 regarding the need to update several procedures was still open as of the inspection, and the changes had not been implemented. Another was signed to indicate that corrective actions and effectiveness verification were completed in November 2014, but the CAPA was not approved and closed until March 2017.
The facility also failed to perform internal quality audits required by its standard operating procedures.
The investigators found that the company had not properly established complaint handling procedures. Out of 12 complaint records the FDA reviewed, several had no documentation of whether the complaint should be reported to the agency as an MDR.