Rhone-Poulenc acetaminophen bulk plant needs full GMP evaluation -- warning letter.
This article was originally published in The Tan Sheet
Executive Summary
RHONE-POULENC ACETAMINOPHEN FACILITY COMPLETE cGMP EVALUATION NEEDED, FDA states in a Jan. 7 warning letter following up on an Oct. 16-18, 21 and 25 inspection of the company's bulk acetaminophen manufacturing and contract lab in Luling, La. Rhone-Poulenc should submit a written validation protocol for the plant's deionized water system, FDA specifically recommends. The DI system reportedly has been in place since 1978 and draws its feed water from the Mississippi River.