Durham, N.C., USA – 13 June 2016 – Almac Group, the global contract development and manufacturing organisation, is pleased to announce that it’s Clinical Services Business has completed a successful US Food and Drug Administration (FDA) inspection of their Durham, North Carolina facility. The inspection was concluded on Thursday 9th June 2016.
The non-scheduled FDA visit lasted three days. The inspection was extensive and a variety of documentation including validation, e-records and audits were reviewed. The requested documents covered deviation, change control, data integrity and training. There were no verbal or written observations and consequently no 483 was issued.