483
Siegfried Pharma AGFDA 483 - Siegfried Pharma AG - December 13, 2019
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Record Details
Siegfried Pharma AG in Zofingen, Switzerland, was cited for five observations during an FDA inspection. The inspection revealed significant deficiencies in laboratory controls, including inadequate impurity and dissolution testing, as well as issues with equipment design and cleaning. Additionally, the firm failed to conduct appropriate annual product quality reviews.
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ID · 167d4267-9147-4ddf-be4b-2898ea972584