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 Puerto Rico Jayuya Warning Letter 1/20/2011
Warning Letter January 20, 2011 Baxter Healthcare Puerto Rico 1. The Jayuya Facility (Puerto Rico) A. CGMP Violations 1. Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. § 211.192]. For example, investigations, (b)(4) and (b)(4) … [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...]
Warning Letter McGuff Pharmaceuticals CGMP Violations 12/28/10
McGuff Pharmaceuticals Inc 12/28/10 Warning Letter CGMP Violations  Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. §211.192] For example, your firm failed to conduct adequate investigations into action level … [Read more...]
