Executive Summary

Whitehall-Robins' Orudis KT: FDA suggests company should "submit the blend uniformity and content uniformity validation data to the NDA reviewer at the Center for Drug Evaluation & Research for evaluation" in the event the company decides to resume production of the OTC NSAID at its Guayma, Puerto Rico manufacturing facility. FDA makes the suggestion in a Sept. 25 warning letter to the American Home Products firm. The warning letter follows a June 9-Aug. 11 inspection of the facility and FDA observations about out-of-spec lots and failure to have adequate acceptance criteria for testing of Orudis KT. As a result of the agency's FD 483 inspections report, Whitehall-Robins initiated a recall of one lot of the product Sept. 9...