WARNING LETTER FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH (con't) 2. Your firm has not established separate or defined areas or such other control systems as necessary to prevent contamination or mix-ups during aseptic processing. [21 C.F.R. § 211.42(c)]. For example, a) The airflow velocity inside critical areas of the aseptic processing operations of Line … [Read more...]
Steris Corporation Warning Letter February 9, 2011
Warning Letter February 9, 2011 Steris Corporation “Chemical Indicators (Verify SixCess Class 6 Challenge Packs and Chemical Indicators) Should Not Replace Biological Indicators (BIs)” Comment Steris Corporation has developed chemical indicators that have been approved by the FDA to “monitor physical conditions”. While the FDA has approved this use, they recently issued … [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...]
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...]
