FDA EIR - AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care - December 06, 2018

An FDA inspection of AMCOL Health & Beauty Solutions, an active pharmaceutical ingredient manufacturer located in Lafayette, LA, was conducted from December 4-6, 2018. The inspection, performed under the relevant regulatory framework for pharmaceutical manufacturing, assessed the firm's quality, raw materials, laboratory, manufacturing processes, facilities, equipment, and packaging systems.The inspection revealed several significant compliance issues. Notably, the company failed to locate and track retain samples for a specific retinol product lot, a violation of regulations concerning product traceability. Additionally, critical manufacturing equipment, such as pressure gauges on reactors and storage vessels, lacked proper identification and current calibration status, indicating a lapse in equipment control. The inspection also identified deficiencies in the firm's corrective and preventative action (CAPA) system. Specifically, corrective actions to address product discoloration exceeded target dates without adequate justification or assessment of impact. Furthermore, these "trial and error" CAPA activities were performed within the manufacturing environment using saleable products, rather than in a controlled research and development setting.Following the inspection, an FDA Form 483, Inspectional Observations, was issued, outlining these findings. AMCOL Health & Beauty Solutions committed to providing a written response within 15 days, detailing their plans to address the observed deficiencies and comply with regulatory requirements. The FDA emphasized the firm's obligation to adhere to federal drug manufacturing laws to avoid potential enforcement actions.