483
Occlutech GmbHOcclutech GmbH – FDA 483, Jun 2, 2022
Record Details
An FDA inspection of Occlutech GmbH in Jena, Germany, revealed two significant quality system deficiencies. The firm was cited for inadequate process validation and deficiencies in its corrective and preventive action procedures. These observations indicate a need for improved quality management practices at the medical device manufacturer.
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ID · bb81f29f-c614-4989-90b2-e852efdbb215
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