FDA 483 - Alva Prototypes Inc - December 19, 2023

An FDA inspection of Alva Prototypes Inc, a medical device manufacturer in Pottstown, PA, identified a significant quality system deficiency. The firm failed to document evaluations and remedial actions for out-of-calibration equipment, specifically a caliper used in production that was found to be out-of-calibration for an extended period. This indicates a lapse in maintaining proper control over measurement equipment critical for device quality.