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Tag Archives: pH
A REVIEW OF AN EXTENSIVE ENDOTOXIN WARNING LETTER USING THE NEW FDA “ENDOTOXIN” Q&A AS A BACKDROP
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 … Continue reading
JUBILANT HOLLISTERSTIER RECEIVES WARNING LETTER (2/13/13)
ASEPTIC FILLING FACILITY RECEIVES SIGNIFICANT OBSERVATIONS Jubilant HollisterStier located in Kirkland, Quebec, Canada was audited by the FDA on March 19-26, 2012. Following the receipt of the Form FDA 483, the Company responded on April 13, 2012 to the Observations … Continue reading
Barry A Friedman, PhD LLC 