FDA 483 - AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care - December 04, 2018

Anco Health & Beauty Solutions, a drug manufacturer in Lafayette, LA, was inspected by the FDA, revealing several quality control deficiencies. Observations included a missing retain sample, an unidentified item lacking content or causation status, and issues with corrective and preventive action (CAPA) processes. Specifically, CAPA target dates were exceeded without proper documentation, and trial-and-error actions were conducted in the manufacturing environment with saleable products.