Thoratec Laboratories 3/10/00″..4. .The implementation of corrective and preventative action (CAPA) procedures at your firm is incomplete in that your procedures do not include reference to the Access electronic database. This database captures information from sources such as complaints and nonconformance reports for use during management reviews. In addition, battery assembly defects, such as loose connectors, were recognized by the UPS assembly inspector. However, the defective assemblies were reworked without generation of a nonconforming product report. [21CFR 820.100(b)] ”
