FDA 483 - Twincraft Inc. - August 25, 2020

Twincraft Inc., an OTC drug manufacturer in Winooski and Essex Junction, VT, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate active ingredient control, overdue equipment calibration, deficient laboratory recordkeeping, lack of microbial monitoring for product contact materials, and poor equipment maintenance. These issues indicate significant concerns regarding quality control and manufacturing practices for OTC drug products.