Almac’s North Carolina Facility Passes FDA Inspection
Almac Group, a contract development and manufacturing organization, reports that its facility in Durham, North Carolina of its Clinical Services Business has completed a successful inspection by the US Food and Drug Administration.
The FDA inspection was concluded on Wednesday, 8 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.