REPEAT VIOLATION CITES CRITICAL DEFECTS THAT CAN IMPACT PRODUCT STERILITY AND STABILITY The FDA recently audited two Baxter Healthcare facilities to include Marion, NC (November 7 to 16,2012) , and Jayuya, Puerto Rico (March 13, 2013 to April 19, 2013). Their Investigators identified significant violations of current good manufacturing practice (CGMP) regulations … [Read more...]
Baxter Healthcare Puerto Rico Warning Letter 1/20/11
Warning Letter January 20, 2011 Baxter Healthcare Puerto Rico 1. The Jayuya Facility (Puerto Rico) A. CGMP Violations 2. Your firm failed to ensure your container closure system provided adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product [21 C.F.R. § 211.94(b)]. For example, your … [Read more...]
