WYETH-AYERST FOLLOW-UP OF DRUG QUALITY PROBLEMS CRITICIZED BY FDA
Executive Summary
WYETH-AYERST FOLLOW-UP OF DRUG QUALITY PROBLEMS CRITICIZED BY FDA in a July 8 warning letter. The company's follow-up investigations into quality problems with antibiotic products and subsequent conclusions are "grossly inadequate and scientifically unsound," a warning letter from FDA's Philadelphia District Office declares. The warning letter resulted from an April 24 through June 14, 1994 routine inspection of Wyeth-Ayerst's West Chester, Penn. manufacturing facility.