Issued: 9/26/11
Region: Southeast
Category: Drug 483s
Inspection date range: 9/19/11-9/26/11
Pages: 5
Company: Horizon Pharmaceuticals, Inc.
971 W. 15th St.
West Palm Beach, FL 33404-6719
Inspector(s): Noreen Muniz
Observations: Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
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