FDA 483 - Kor- Chem Inc - May 05, 2023

Kor- Chem Inc, an OTC drug manufacturer in Atlanta, GA, was cited with 10 observations during an FDA inspection from April 26 to May 5, 2023. The inspection revealed significant deficiencies in process validation, laboratory controls, quality unit responsibilities, and documentation practices, particularly concerning their hand sanitizer drug products. Several observations were repeats from a previous FDA 483 dated March 2004, indicating persistent non-compliance with cGMP regulations.