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...]