Bioreliance Ltd.September 27, 2019

FDA 483 - Bioreliance Ltd. - September 27, 2019

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Record Details

An FDA inspection of Bioreliance Ltd. in Glasgow, United Kingdom, a manufacturer of API starting material and control testing laboratory, revealed three significant observations. These included failures to follow written sanitation procedures for equipment cleaning, deficiencies in aseptic simulations for operator qualification, and a lack of quality unit review for equipment changes or repairs during on-demand maintenance.

Company: Bioreliance Ltd.
Inspection Date: September 27, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Joey Y Quintana

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ID · ad0ac3f7-301c-407d-b274-68e2753f4c99