483
Harman Finochem LimitedFDA 483 - Harman Finochem Limited - March 18, 2024
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An FDA inspection of Harman Finochem Ltd. in Aurangabad, India, revealed deficiencies in laboratory controls. Specifically, the firm's methods for microbiological analysis of water used in non-sterile active pharmaceutical ingredient production were not scientifically sound, lacking proper validation and justification for testing procedures. This indicates a significant concern regarding the quality assurance of raw materials.
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ID · 21b993cf-a4a3-45d8-bb8e-2c7561d4da21