Biotronik SE & Co. KGJune 23, 2022

FDA 483 - Biotronik SE & Co. KG - June 23, 2022

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Record Details

An FDA inspection of Biotronik SE & Co. KG, a class III device manufacturer in Berlin, Germany, identified a significant issue regarding the documentation of corrective and preventive action (CAPA) activities. The firm failed to adequately document these critical quality system processes. This indicates a deficiency in the firm's adherence to quality system requirements for medical device manufacturing.

Company: Biotronik SE & Co. KG
Inspection Date: June 23, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Dedicated Device Cadre
Daniel J. Lahar (Cso)

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ID · c417df4d-301e-4ab4-85c1-e8f5b4435908