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Drugs may be deemed adulterated under section

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When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. Review FDA's guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. Provide examples of what a company should do and not do to avoid a product being deemed adulterated in this way and explain why your examples should and should not be done.

Reference no: EM133501246

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