FDA EIR - Alkermes Pharma Ireland Ltd - June 21, 2019

An FDA surveillance inspection of Alkermes Pharma Ireland Ltd., located in Monksland Industrial Estate Athlone, was conducted from June 17 to June 21, 2019. The inspection, performed under regulatory guidance CP 7346.832 (PAC 46832) and utilizing a system-based approach, assessed the firm's quality, materials, production, facilities & equipment, packaging & labeling, and laboratory control systems for drug products.

While no formal FDA-483 observations were issued, twelve verbal observations were discussed. Key issues included an unqualified tablet press rejection system, inaccurate end-of-batch reports, and an unstable balance setup potentially compromising measurement accuracy. Documentation deficiencies were noted, such as missing yield calculations, reversed equipment numbers in batch records, and inconsistent rounding. Sampling procedures for microbiology and raw materials required revision for representativeness or proper handling. Additionally, labeling discrepancies for stability samples, incorrect programming for dissolution testing, and deficiencies in calibration Standard Operating Procedures and product recipes were identified.

Alkermes Pharma Ireland Ltd. voluntarily addressed these deficiencies during the inspection through investigations or revisions to their Standard Operating Procedures. As a result, the inspection concluded with a "No Action Indicated (NAI)" classification, signifying that the identified issues were resolved to the FDA's satisfaction without requiring further regulatory action.