FDA 483 - Bioreliance Ltd.

An FDA inspection of BioReliance Limited in Glasgow, Scotland, revealed numerous deficiencies across equipment, facilities, quality systems, and laboratory controls. The firm failed to maintain equipment in a qualified and calibrated state, exhibited unreliable data in its equipment tracking system, and had inadequate storage space. Significant issues were also noted in timely corrective action implementation, client notification of deviations, and environmental monitoring practices, indicating a lack of robust quality oversight.