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Almac Clinical Services Completes Successful Inspection

FDA finds North Carolina facility in compliance

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By: Kristin Brooks

Managing Editor, Contract Pharma

Almac Group’s Clinical Services Business has recently completed a successful FDA inspection of its Durham, NC facility. The three-day inspection reviewed documentation including validation, e-records and audits. The requested documents covered deviation, change control, data integrity and training. There were no verbal or written observations and no 483 was issued.   Christi Gimber, director of Quality at Almac Clinical Services said, “We are delighted with the results of this latest inspectio...

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