483
Harman Finochem LimitedHarman Finochem Limited – FDA 483, Mar 18, 2024
Record Details
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
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