FDA 483 - AIAC International Pharma, LLC - June 01, 2018

During an inspection from May 22 to June 1, 2018, Actac International Pharma, LLC in Arecibo, PR, a drug manufacturer, was cited for failing to follow written production and process control procedures and for inadequate documentation. This included incomplete laboratory logbook entries for lot approvals and a delayed notification to a supervisor regarding a power failure and humidity excursion that impacted an API batch.