483
Rottendorf Pharma GmbhFDA 483 - Rottendorf Pharma Gmbh
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Record Details
An FDA inspection of Rottendorf Pharma Gmbh, a drug product manufacturer in Ennigerloh, Germany, identified deficiencies in their instrument calibration procedures. Specifically, the firm failed to adequately evaluate the linearity and accuracy of a mass balance used for in-process testing of core tablets at critical lower weight ranges. This indicates a potential gap in ensuring the quality and consistency of their drug products.
- Company
- Rottendorf Pharma Gmbh
- Product Type
- Drugs
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ID · 23a72691-d661-41b4-be4a-22890cfeda8f