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...]
Baxter Receives Warning Letter Puerto Rico 1/27/11
Baxter Receives Warning Letter (1/27/11) Baxter received a FDA Warning Letter yesterday (January 27, 2011) for two of its facilities in Puerto Rico. The Warning Letter was announced by Baxter. The FDA has not issued the Warning Letter on its Web site as of Friday, January 28, 2011 … [Read more...]
