Janssen Biotech, Inc.May 18, 2017

FDA 483 - Janssen Biotech, Inc. - May 18, 2017

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Record Details

During an inspection, Janssen Biotech, Inc. in Malvern, PA was cited for incomplete written records of investigations. Specifically, the firm failed to adequately investigate out-of-specification batches of Bovine APO Transferrin and a decrease in process capability for API Pre-formulated Bulk Bioactivity Assay. These issues indicate deficiencies in the firm's quality control unit and investigation procedures.

Company: Janssen Biotech, Inc.
Inspection Date: May 18, 2017
Product Type: Biologics
Office: Philadelphia District Office
Person: Anita R. Michael (Investigator)

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ID · 49d46fef-c43c-4edf-92a6-85e4dd41c6cb