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U.S. FDA expectations and experiences when inspecting Indian drug and API manufacturers.

  • At: 2011 FIP Congress in Hyderabad (India)
  • Type: Presentation
  • By: ROSS, Bruce (U.S. Food and Drug Administration, Delhi, India)
  • Abstract:

    This talk will cover some of the expectations for a pharmaceutical GMP or pre-approval inspection conducted by the U.S. Food and Drug Administration, covering common citations and issues identified  while providing the audience with some solutions and areas that improvements might be made at the firm to reduce findings or a 483-issuance.

    Presenting

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Last update 4 October 2019

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