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Legacy Pharmaceuticals International.

Article Excerpt
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 tributes of Efudex Topical Cream 5% drug product in the last 2'/z years, the agency noted. Since August 2005, Legacy's analyses of retained lots (as part of complaint investigations) and stability samples (as part of its ongoing stability program) revealed at least 11 instances of failure to meet specifications for assay, appearance and/or content. Other samples from some of these same lots met specifications, which indicated that the manufacturing process was not well-controlled and/or was...

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