Pink Sheet is part of the Informa Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS086640

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel