FDA EIR - Almac Pharma Services Limited - September 06, 2019

The Food and Drug Administration (FDA) conducted a comprehensive surveillance inspection of Almac Pharma Services Limited, a contract drug manufacturer and packing company, from September 2 to September 6, 2019. This inspection adhered to regulatory frameworks CPGM 7356.002 for Drug Manufacturing Inspections and CPGM 7356.002B for Drug Repackagers and Relabelers, covering various drug product profiles. Notably, the current inspection concluded with a "No Action Indicated" (NAI) classification, and no FDA Form 483 (Inspectional Observations) was issued, signifying a favorable outcome regarding compliance. While formal observations were absent, several discussion items were presented to the company during the close-out meeting. This contrasts with Almac Pharma Services' previous FDA inspection, conducted from June 19 to June 23, 2017. That inspection was classified as "Voluntary Action Indicated" (VAI) and resulted in a two-item FDA 483. The main issues cited then included a failure to follow the company's own Standard Operating Procedures (SOPs) for annual product reviews and the inappropriate averaging of out-of-specification (OOS) results with in-specification results. For the recent 2019 inspection, no formal actions were required by the FDA.