FDA 483 - Syntron Bioresearch Inc - June 02, 2025

Syntron Bioresearch Inc, a medical device manufacturer in Carlsbad, CA, received two observations during an FDA inspection. The firm failed to adequately establish procedures for controlling non-conforming products, which led to the release and subsequent recall of its "apphia The Baby Planning Bundle" kits. Additionally, the company has not maintained a device master record for its manufactured devices, indicating significant quality system deficiencies.