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Re: 1234jklm post# 70619

Tuesday, 06/27/2017 10:34:47 AM

Tuesday, June 27, 2017 10:34:47 AM

Post# of 144812
How does FDA determine if a company is complying with CGMP regulations?

FDA inspects pharmaceutical manufacturing facilities worldwide, including facilities that manufacture active ingredients and the finished product. Inspections follow a standard approach and are conducted by highly trained FDA staff. FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the CGMP regulations.

https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
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