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...]
NOVO NORDISK A/S RECEIVES WARNING LETTER (Bagsvaerd, Denmark, 12/12/12)
LACK OF ENVIRONMENTAL MONITORING DURING 23 MONTHS ATTRACTS FDA ATTENTION Approximately one year ago (March 12 - 20, 2012), the FDA audited the Novo Nordisk A/S facility located at Novo Alle, Bagsvaerd, Denmark. During the audit the FDA encountered significant deviations that lead to the following Warning Letter. Observation 1 states that “your firm has not established or … [Read more...]
