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.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning