APP Pharmaceuticals ("APP"), a subsidiary of Fresenius Kabi, has received a warning letter dated 22 February 2012 from the New York District FDA office regarding the Company's Grand Island plant. The warning letter follows an inspection at the facility which concluded in July 2011. The Company responded on 27 July 2011 detailing the corrective and preventative actions planned to address the Agency's concerns, and since then has made significant progress in collaboration with the FDA in remedying these issues. In addition, the warning letter refers to the marketing status of five 'grandfathered' generic products with a total annual sales volume zg yugcpf. p70 wnxkfvs.
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