FDA 483 - Alliance Precision Plastics Corporation - June 04, 2021

An FDA inspection of Alliance Precision Plastics Corporation, a medical device contract manufacturer in Rochester, NY, revealed significant quality system deficiencies. Observations included inadequate software validation for production and measurement equipment, poorly established procedures for in-process product acceptance, and insufficient corrective and preventive action processes. These issues indicate a lack of robust quality controls for critical manufacturing and quality assurance activities.