FDA 483 - AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care - April 25, 2025

AMCOL Health and Beauty Solutions Care, a drug manufacturer in Lafayette, LA, was inspected by the FDA. The inspection revealed significant issues including inadequate investigations into out-of-specification results and customer complaints for OTC drug products, as well as a failure to properly test and release drug product containers before use. These findings indicate deficiencies in quality control and manufacturing processes.