Bavarian Nordic Berna GmbH

FDA 483 - Bavarian Nordic Berna GmbH

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An FDA inspection of PaxVax Berna GmbH in Thörishaus, Switzerland, an oral vaccine manufacturer, identified two observations related to incomplete validation activities. Specifically, the firm failed to complete shipping validation for a drug product and validation of the drug supply chain security for a packaging line. These issues indicate potential deficiencies in quality control and supply chain management.

Company: Bavarian Nordic Berna GmbH
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Gregory Price
Richard Heath Coats

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ID · 2c6d1575-178d-481f-bd66-7b69090ec8dd