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 Healthcare Corp Puerto Rico Warning Letter – Just Issued
The FDA just announced the Warning Letter for Puerto Rico - Comments to follow Baxter Healthcare Corporation 1/20/11   Department of Health and Human Services Public Health Service Food and Drug Administration  San Juan District 466 Fernandez Juncos Avenue San Juan Puerto Rico 00901-3223 Telephone: 787-474-9500 FAX: … [Read more...]
