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483
•Harman Finochem Limited•March 18, 2024

FDA 483 - Harman Finochem Limited - March 18, 2024

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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.

Company
Harman Finochem Limited
Inspection Date
March 18, 2024
Product Type
Drugs
Office
Center for Veterinary Medicine
Person
  • Lisa L. Flores (Consumer Safety Officer/ Federal Investigator)
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ID · 21b993cf-a4a3-45d8-bb8e-2c7561d4da21

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