Where are you now? Intelligence Services > Endotoxin > Related Warning Letters
LAL-Endotoxin Related Warning Letters
These files are in Adobe PDF format.
Click on the "Get Acrobat Reader" icon on the left of the page to
download a free copy of the Acrobat Reader.
Cleveland Clinic Foundation, 2002-03-26
"You did not perform the protocol-required tests for endotoxin and
mycoplasma prior to the infusion of the investigational xxx for all study subjects."
Dayton Water Systems, 2002-03-14
"The cause was that the LAL test results were not within specifications....There was no documentation that a failure investigation was performed and no corrective action was implemented for the LAL test failures."
Tyco International Ltd., 2002-03-08
"Radionics' Pyrogen Procedure QS3-09-0065, Rev. A does not specify that all implanted device configurations be tested for pyrogenicity."
Medical Device Services, Inc., 2001-12-13
"The validation testing for sterilization process, LAL bioburden, and residuals will be completed by October 10, 2001. This response is inadequate in that calibration by itself cannot provide assurance that the requirements of a sterilized product can be consistently fulfilled."
Ferro Corporation, 2001-07-06
"Investigations were not completed for several incidents of Purified Water not meeting specifications for microbial contamination and endotoxin levels during the Performance Qualification testing."
Eli Lilly and Company, 2001-03-02 | 
PDF file (323 KB)