PPD Development Ireland Ltd. – FDA 483, Dec 19, 2025
An FDA inspection of PPD Development Ireland Ltd. in Athlone, Ireland, a contract laboratory testing facility, revealed significant deficiencies in their quality control unit's adherence to procedures. The firm consistently failed to complete stability testing within required windows for drug substances and products, despite numerous deviations and corrective actions over several years. Additionally, the company applied a complexity classification to quality control testing methods without providing adequate comprehensive hands-on training, contributing to a high rate of operator-related errors.
ID · 0b0663bb-38e7-4ceb-b2aa-291ecd992730
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