FDA EIR - Unknown Company - September 26, 2006

This FDA Establishment Inspection Report details a compliance inspection of PCI Technology, a manufacturer of sterile and non-sterile medical devices, conducted from September 25-26, 2006. The inspection, carried out under CP 7382.845 for Medical Device Manufacturers, served as a follow-up to a previous inspection (August 15-31, 2005) and a subsequent warning letter issued on October 18, 2005.

The earlier inspection revealed eleven significant deficiencies related to Quality System Regulations. These included incomplete design procedures, inadequate documentation of design inputs and outputs, absence of design risk analysis, lack of design review, verification, and validation, non-adherence to design transfer procedures, insufficient calibration procedures, and failures in packaging validation.

During the 2006 follow-up inspection, no formal FDA 483 observations were issued, indicating that all previous deficiencies were corrected. However, investigators discussed two new concerns with company management: the failure to document burst testing after packaging material roll changes and the Quality Unit's oversight in detecting transposed numbers in packaging validation records. Management committed to investigating these issues. The overall classification for this inspection was "No Action Indicated" (NAI), with a reschedule suggested for October 2008.