Fehling Instruments GmbH & Co. KGAugust 4, 2022

FDA 483 - Fehling Instruments GmbH & Co. KG - August 04, 2022

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Fehling Instruments GmbH & Co. KG, a medical device manufacturer in Karlstein, Germany, was inspected by the FDA from August 1-4, 2022. The inspection revealed that the firm's procedures for controlling nonconforming products were not adequately established. This indicates a significant issue with the firm's quality system regarding product control.

Company: Fehling Instruments GmbH & Co. KG
Inspection Date: August 4, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Jude C. Dike

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