AG Hair Limited Warning Letter Details

Summary

AG Hair Limited, a Canadian drug manufacturer, received a warning letter for significant Current Good Manufacturing Practice (CGMP) violations in their finished pharmaceutical operations. The FDA inspection identified critical failures in batch investigation procedures, including inadequate investigation of elevated bioburden counts in a non-circulating water system prior to drug manufacturing and insufficient investigation of a customer complaint involving product irritation using only four employee participants. The company's July 2022 response to FDA's initial inspection findings was deemed inadequate for lacking sufficient detail and evidence of corrective actions needed to achieve compliance with CGMP regulations, rendering their drug products adulterated.