I work for a parenteral fill/finish contract manufacturer. We've outgrown our warehouse, and are validating a new warehouse that lies within the five-mile radius specified for a "prescription drug establishment". Under the March, 2014, Guidance on "CMC Postapproval Manufacturing Changes to be Documented in Annual Reports", does anyone know what level of notification the FDA would expect to receive? -------------------------------------------
Charles Van Beveren RAC
San Diego CA
United States
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