FDA 483 - Dr Franz Koehler Chemie Gmbh - April 11, 2024

Dr Franz Koehler Chemie GmbH, a manufacturer of Class 2 medical devices, received three observations during an FDA inspection. The firm failed to report a device field corrective and removal action to the FDA within the required 10 days. Additionally, deficiencies were noted in their procedures for design changes and acceptance activities for raw materials and packaging.