GENERAL The following Blog was initially published on October 1, 2012. Teva Parenterals Medicines had received a Warning Letter in December 2009 describing extensive issues with Endotoxin. To obtain more information on this subject, please plan to attend a webinar on Wednesday, September 9 sponsored by Tungsten Shield and COMMENT In … [Read more...]
ID BIOMEDICAL CORP RECEIVES WARNING LETTER (6/12/14)
COMPANY CONTINUED TO FIND GRAM NEGATIVES IN PW WATER SYSTEM ID Biomedical Corp, a subsidiary of GSK Biologicals, located in Quebec, Canada was audited by the FDA from March 31 through April 9, 2014. The FDA Investigators documented deviations from CGMP in the manufacture of their biological drug product, Flulaval and its intermediates. Significant objectionable conditions … [Read more...]
ABBEY COLOR, PHILADELPHIA, PA RECEIVES WARNING LETTER (FEBRUARY 19, 2013)
API MANUFACTURING FACILITY IS CITED FOR SEVERAL REPEAT WATER RELATED OBSERVATIONS During the time frame of March 13 to March 23, 2012 the FDA inspected Abbey Color, an active pharmaceutical ingredient (API) manufacturing facility in Philadelphia, PA. Following a detailed review of the firm’s response, dated April 12, 2012, the FDA concluded that … [Read more...]
PYROGEN AND ENDOTOXIN TESTING: QUESTIONS AND ANSWERS (06/12) JUST ISSUED
The FDA just published their final Guidance for Industry Pyrogen and Endotoxin Testing: Questions and Answers. FDA has determined that previously published USP and AAMI documents describing methods and calculation of pyrogen and endotoxin testing limits provide industry with appropriate information. However, because the compendial chapters and standards do not address certain … [Read more...]
