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483
•Fehling Instruments GmbH & Co. KG•August 4, 2022

Fehling Instruments GmbH & Co. KG – FDA 483, Aug 4, 2022

Record Details

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
View Company Profile

ID · fa98724b-03ff-468d-8cf0-199a4ce34b2f

Other documents for Fehling Instruments GmbH & Co. KG
  • WARNING_LETTER - 2015-06-18June 18, 2015

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