FDA 483 - Pegasus Research Corporation - February 21, 2020

An FDA inspection of Pegasus Research Corporation, a medical device manufacturer in Santa Ana, CA, revealed significant quality system deficiencies. The firm lacked adequate procedures for design validation, environmental controls for aseptic assembly, and equipment calibration. Additionally, personnel training was undocumented, Medical Device Reporting procedures were incomplete, and internal quality audits were conducted by individuals with direct responsibility for the audited areas.