FDA Inspections of Compounding Outsourcing Facilities

FDA provides an overview of the inspection process for compounding outsourcing facilities and discusses what to expect during an inspection, from initiation to closeout as well as observations on successes and challenges. Other topics include the following: Current Good Manufacturing Practices (CGMPs) for outsourcing facilities, insanitary conditions, initial facility walk-through, aseptic operators and operations, process and facility design, cross contamination, environmental and personnel monitoring, product inspection and component control, packaging and labeling control, records review and evaluation of compliance with section 503B of the FD&C Act.
Presenters are from CDER’s Office of Compliance and the FDA Office of Regulatory Affairs.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.   

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