Absolute Medical GmbH

FDA 483 - Absolute Medical GmbH

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Record Details

An FDA inspection of Absolute Medical GmbH in Borken, Germany on August 2, 2024, revealed two significant observations. The firm failed to adequately validate a process for dental implant products and did not establish adequate procedures for corrective and preventive actions, specifically lacking documentation of corrective action effectiveness.

Company: Absolute Medical GmbH
Product Type: Device
Office: International Compliance Team
Person: Stephen D. Eich (investigator)

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ID · 23994da2-041c-42b4-8fb9-d0ee84eb7e1d