FDA 483 - ABRYL LABORATORIES PRIVATE LIMITED - August 20, 2024

Abryl Laboratories Private Limited, a sterile drug manufacturer in Dera Bassi, India, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included a lack of scientifically sound sampling plans and test procedures, failure to thoroughly investigate non-viable particle excursions, and inadequate qualification of visual inspectors for drug product inspection. These issues indicate a lack of robust controls to ensure drug product quality and purity.