Texas drug manufacturer smacked with FDA warning letter over multiple violations
A Texas drug manufacturing facility has drawn the FDA’s ire over missing records, inadequate processes and faulty controls on a laundry list of infractions outlined in an agency warning letter.
Fort Worth-based Monarch PCM, which makes pharmaceutical liquids, tablets, creams and lotions among other products, was inspected by the FDA from June through August last year. The new FDA warning letter dated June 10, 2022, listed the company’s methods, facilities and controls for a range of manufacturing and processing issues that did not conform to current good manufacturing practices (CGMP).
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