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Home » How the FDA Decides What Letters to Send to GMP Violators
How the FDA Decides What Letters to Send to GMP Violators
What type of notification the FDA will provide to a drug or biologics company that may not be complying with good manufacturing practices (GMP) depends on several factors, including the type of problem, the law and the agency’s internal regulatory procedures manual, agency officials said at the FDA/Parenteral Drug Association (PDA) joint regulatory conference.