FDA 483 - Bioreliance Ltd.

An FDA inspection of BioReliance Limited in Glasgow, United Kingdom, revealed multiple deficiencies across its manufacturing and testing operations. Key issues included inadequate aseptic techniques leading to cross-contamination, untimely implementation of corrective actions, and failure to follow written sanitation procedures. The firm also had inadequate disinfectant effectiveness studies, incomplete investigation records, deficient batch production documentation, and insufficient media simulation studies.