GRUNENTHAL GMBHJuly 10, 2000

FDA 483 - GRUNENTHAL GMBH - July 10, 2000

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Record Details

GRUNENTHAL GMBH, a bulk drug manufacturer in Germany, was cited during an FDA inspection for a quality control deficiency. The firm's Finished Bulk Product laboratory lacked a formal "rounding" document, which resulted in inconsistent analytical results for product purity. This issue highlights a potential weakness in their laboratory data integrity and procedural controls.

Company: GRUNENTHAL GMBH
Inspection Date: July 10, 2000
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: RICHARD H. PENTA

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ID · c760db76-3579-46aa-bfd1-20fb53151ff0