FDA 483 - Midlab Incorporated - August 05, 2022

Midlab Incorporated, an OTC drug manufacturer in Athens, TN, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in manufacturing process validation, microbial testing, stability programs, component identity testing, quality control unit responsibilities, and reprocessing procedures. These issues indicate a lack of adequate controls for ensuring consistent drug product quality and safety.