FDA EIR - Amerisource Health Services LLC - June 15, 2017

An FDA inspection of Amerisource Health Services in Columbus, OH, was conducted from June 6 to June 15, 2017. The company operates as a repackager and packager of drug products, handling items in unit dose packages, bottles, and pouches. This inspection followed a previous assessment in 2012 which resulted in a 'Voluntary Action Indicated' classification. During the 2017 review, specific packaging operations, such as the blistering of certain tablets, were observed. As a result, a three-item FDA-483, Inspectional Observations, was issued to President Bruce L. Bennett. The primary issues identified included the company's failure to complete necessary investigations within its own specified timeframes and a failure to consistently adhere to written procedures, particularly concerning environmental controls. These observations indicate a deviation from fundamental Good Manufacturing Practices (GMP) required for drug product handling. Amerisource Health Services is now required to address these deficiencies by implementing comprehensive corrective and preventive actions to ensure compliance with federal regulations governing pharmaceutical quality and safety.