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...]
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...]
