FDA 483 - GLOBAL WIDGET LLC - November 17, 2023

GLOBAL WIDGET LLC, a drug manufacturer in Tampa, FL, was cited for significant deficiencies in its quality control and production systems during an FDA inspection. Observations included inadequate raw material and finished product testing, a non-compliant quality unit lacking written procedures and oversight, and a failure to establish proper production and process controls, including process validation and equipment qualification. These issues raise concerns about the identity, strength, purity, and quality of their OTC drug products.