AIAC International Pharma, LLCJune 1, 2018

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

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Record Details

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.

Company: AIAC International Pharma, LLC
Inspection Date: June 1, 2018
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East IV
Person: Marian E. Ramirez (investigator)

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ID · 03bfa2c8-129d-423f-898b-eba4f0ee2c71