FDA 483 - NEW LIFE DIAGNOSTICS LLC - February 27, 2019

NEW LIFE DIAGNOSTICS LLC, a medical device manufacturer in Carlsbad, CA, was inspected from February 25-27, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process controls, equipment calibration, acceptance activity documentation, purchasing controls, and complaint handling procedures. These issues indicate a broad lack of established and followed quality system procedures.