FDA 483 - Angiplast Private Limited - January 30, 2020

Angiplast Private Limited, a medical device manufacturer in Daskroi, India, was cited for significant quality system deficiencies during an FDA inspection. The inspection revealed failures in establishing adequate procedures for incoming product acceptance, corrective and preventive actions, purchasing controls for foreign suppliers, and equipment calibration. These issues indicate a lack of robust quality management practices impacting device quality and safety.