ZENITH ANALYTICAL METHODS VALIDATION FAILURES CITED IN WARNING LETTER
Executive Summary
ZENITH ANALYTICAL METHODS VALIDATION FAILURES CITED IN WARNING LETTER issued by FDA June 2. The letter followed inspections of Zenith Labs' Cidra, Puerto Rico manufacturing facility from February to May. The inspectors found that Zenith's "manufacturing processes, testing and release procedures" were insufficient for five products: prazosin 1, 2 and 5 rag; nitrofurantoin 50 and 100 mg; diazepam 1 rag; fenoprofen 600 mg; and pindolol 5 and 10 mg.