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Home » German Laparoscopy Maker Gets FDA Warning Letter for cGMP Lapses
German Laparoscopy Maker Gets FDA Warning Letter for cGMP Lapses
The FDA has issued a warning letter to Nendingen, Germany-based laparoscopy devicemaker Getsch+Hiller Medizintechnik (GH) for unapproved product changes, the lack of a design history file and other lapses observed during a July 2022 inspection.