Pink Sheet is part 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

Bayer plasma sterility validation procedures cited in FDA warning letter.

Executive Summary

BAYER PLASMA PLANTS' STERILITY FAILURE INVESTIGATIONS CITED BY FDA in a warning letter sent to the company Jan. 30. The letter stemmed from an Aug. 18-Oct. 14 inspection at Bayer's Clayton, N.C. facility and a Dec. 1-11 inspection at its Berkeley, Calif. facility. "Investigations of product sterility failures at Clayton do not extend to other products or processes which could be effected by the failure," the letter states, and standard operating procedures do not lay out investigation procedures in proper detail. At both facilities, the "sterilization validation program fails to demonstrate that equipment and components used in aseptic manufacturing are sterilized" to an appropriate sterility assurance level and microbial challenge level, the letter adds.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS031653

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