APIs WERE MISBRANDED Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China) was inspected from October 21-24, 2013 at their active pharmaceutical ingredient manufacturing facility. Deviations from CGMP were noted in the manufacture of the API. “Failure to implement an effective system of managing quality and failure to transfer all quality or … [Read more...]
FDA Safety Communication: Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators — Revised Expiration Dates
Date Issued: July 3, 2012 Medical and Surgical Specialties: General Surgery, Surgical Technology, and any specialty that uses devices that must be sterilized at low temperatures Device: The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product used periodically to monitor and confirm the microbicidal effectiveness of the … [Read more...]
