BioConnection B.V.March 4, 2024

FDA 483 - BioConnection B.V. - March 04, 2024

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Record Details

An FDA inspection of BioConnection in Oss Noord-Brabant, The Netherlands, identified two significant observations. The firm's microbial cross-contamination control was deemed inadequate due to improper handling practices during filling line operations. Additionally, the environmental and personnel monitoring techniques, specifically finger dab and surface contact plate sampling, were found to be insufficient.

Company: BioConnection B.V.
Inspection Date: March 4, 2024
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Michael R. Shanks (Investigator)

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ID · 20a279ff-6d28-476a-8a26-91b64377573b