June 5, 2001
483Company: Schering-Plough Prodcuts, LLC City and State: Las Pierdas, PR FDA District: San Juan, Puerto Rico Dates of Inspection: 5/1-6/5-2001 You have not developed validation/qualification master plans encompassing process, cleaning computer and analytical method validation as directed by the Corporate Quality Assurance Guideline titled Master Plans for Validation/ Qualification issued 10/12/1999. You failed to have...
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