DESANO PHARMACEUTICALS PRIVATE LIMITED – FDA 483, Jun 6, 2025
Desano Pharmaceuticals Private Limited in Bengaluru, India, received a Form 483 with four observations during an FDA inspection. The firm was cited for deficiencies in batch production and control records, inadequate procedures for preventing objectionable microorganisms in non-sterile drug products, failure to follow written procedures for component qualification, and insufficient assurance of data backup integrity. These issues highlight significant concerns regarding quality control, environmental monitoring, vendor management, and data management practices.
ID · f6d23a8a-738c-4f55-8d13-f8bc49973f4e
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