FDA 483 - Bioreliance Ltd. - March 23, 2016

An FDA inspection conducted from March 14-23, 2016, at BioReliance Limited, a manufacturer and contract testing laboratory in Glasgow, Scotland, revealed significant operational deficiencies. The observations, documented on an FDA Form 483, highlighted a lack of adherence to regulatory expectations for quality and control.

Key issues included widespread failures in equipment management; many critical pieces of equipment, such as incubators, freezers, and HPLC systems, were found to be overdue for requalification, calibration, or maintenance. The company's electronic tracking system for equipment status was identified as unreliable and inaccurate. Facility inadequacies, such as insufficient space for orderly material placement, also contributed to product integrity risks.

The quality system exhibited several weaknesses, including untimely implementation of corrective actions, leading to recurring issues like out-of-specification bioburden results. Deviations with potential product impact were not consistently reported to clients within required timeframes, and Product Quality Reviews were often delayed. The firm lacked a formal procedure for Biological Product Deviation Reporting and performed insufficient trending of environmental monitoring data. Production activities were sometimes conducted using non-conforming equipment, and critical processes like visual product inspection and personnel monitoring showed inadequacies. Finally, the laboratory system reported test results as "Pass" despite not meeting client validity criteria and exhibited inconsistencies in growth promotion testing.

BioReliance Limited is expected to provide a comprehensive response detailing its corrective and preventive actions to address these observations and ensure compliance with regulatory standards.