Consultants Specializing in Regulatory Affairs for FDA Compliance

Quality System Audits

Your Quality System is a living document and may undergo changes purposely or sometimes inadvertently. Subtle changes or more obvious ones may occur without recognition and change occurring in your SOPs. From my experience, a good many of the 483s occur when the SOPS and the actual procedure do not match. A Quality System audit puts objective eyes on your quality system.

The focus of FDA audits also change from year to year with various aspects of the Quality System receiving closer scrutiny. At the present time the FDA is reviewing Design Control and DMRs to ensure that Design Control was part of the development process but also governs any aspect of change that may impact adherence to FDA approved product specifications.

Smith Associates has conducted many audits pre-FDA inspection and has acted as management representative to the manufacturer in many Class III audits as well as Class II audits.

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