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...]
CHINESE API MANUFACTURING FACILITIES RECEIVE WARNING LETTER (MARCH 30, 2011)
NINGBO SMART PHARMACEUTICAL RELEASE WITH INCOMPLETE C of As Comment The Ningbo Smart Pharmaceutical Co. Ltd, Ningbo China, received an Active Pharmaceutical Ingredient (API) audit between October 25-29, 2010. During this audit, the investigator identified significant deviations from CGMP for the manufacture of APIs. They … [Read more...]
