Birsfelden, Switzerland, May 7 (San Juan District)
An FDA inspection conducted Sept. 10-28 at Legacy's facility in Puerto Rico revealed that the manufacture, processing, packing or holding of the human drug product Efudex Topical Cream 5% deviated from GMP, rendering the drug adulterated.
The company had not established written procedures for production and process control designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess.
Information obtained during the September inspection and from the company's Field Alert Reports (FAR) indicated a pattern of variability in key quality at ...