AAI gets FDA OK for analytical lab

Related tags European union

AAIPharma Services says its analytical lab in Durham, North Carolina has passed its fourth consecutive US FDA audit with no 483 observations.

Christopher Smith, VP of quality assurance and Regulatory Affairs said: "Once again passing the FDA inspection without issue reflects the strong focus on compliance and accurate documentation that is the legacy of AAIPharma Services.

"Having this laboratory testing facility thoroughly audited is a reassurance to our global clients that their pharmaceutical products developed and tested here for clinical and commercial uses will be of the highest quality and meet regulatory standards​."

Earlier this year the European Union (EU) issued GMP Certificates followed audits of the AAI’s Charleston manufacturing and lab for parenteral products and its Wilmington inspection, labelling, packaging, shipping and lab.

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