FDA 483 - Invahealth Inc. - November 21, 2025

Invahealth Inc. in Cranbury, NJ, received a Form 483 following an FDA inspection from November 17-21, 2025. The inspection revealed two significant issues related to facility maintenance and laboratory controls for drug product manufacturing. Specifically, the firm failed to maintain a manufacturing room in good repair and did not qualify secondary reference standards used for testing and releasing OTC drug products.