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 inspection. Almac prides itself on delivering an exceptional level of quality and complete adherence to best practice for our industry. The inspector commented that we are doing GXP training the way it should be done and was very impressed with the program and the variety of topics covered.  He also noticed from review of the Site Master File that most of our staff have been with Almac for many years and felt that said a lot about the kind of company Almac is. I would like to thank all staff who supported the inspection. The result is a testimony to the dedication and effort of our employees who are committed to ensuring that the highest standards are always delivered by Almac.”

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