Baxter has closed out an FDA warning letter issued in January for problems the agency found at two of its Puerto Rico plants, the firm’s CEO Robert Parkinson said in a third-quarter earnings call in late October.
FDA findings during a mid-2010 inspection at Baxter’s facility in Jayuya, Puerto Rico that appropriate action had not been taken to resolve problems reported in complaints and confirmed in the firm’s own internal investigations resulted in a multi-product recall the following month, a follow-up inspection of a companion facility in Puerto Rico two weeks after the recall, and an FDA warning letter covering both facilities three months later in late January (IPQ “In the News, February 6).
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