FDA EIR - Amerisource Health Services LLC - August 16, 2017

An FDA limited directed inspection of Amerisource Health Services, a pharmaceutical repackager and packager located in Columbus, Ohio, was conducted on August 16, 2017. The inspection, carried out under eNSpect Operation ID 65373 and CPGM 7356.021 for Drug Quality Reporting Systems and NDA Field Alert Reports, focused on the firm's operations, specifically the receipt, investigation, and follow-up of reported complaints.

The facility engages in repackaging drug products into unit dose packages, bottles, and unit dose pouches for hospital automatic dosing machines. During the inspection, one Field Alert Report (FAR) detailing complaints, including a potentially serious one involving multiple lots and a patient death, was thoroughly reviewed. The firm's investigation into these complaints, which involved communication with the bulk manufacturer, was deemed appropriate, logical, and complete. They concluded that the incidents were not associated with their repackaging activities and that all repackaging was conducted under Good Manufacturing Practices (GMP).

Crucially, no objectionable conditions were observed by the FDA investigator, and consequently, no Form FDA 483 (Inspectional Observations) was issued. Management was cooperative, and no refusals were encountered during the one-day inspection. As no violations were identified, no specific corrective actions were required from Amerisource Health Services following this inspection.