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news.AAIPharma Services has passed inspection of its Durham analytical lab by the Food and Drug Administration (FDA) with no inspectional observations.
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AAIPharma provides services that encompass the entire pharmaceutical drug development process from early development through commercialization.
The successful FDA audit in Durham comes on the heels of two good manufacturing practices (GMP) certificates issued by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
The European Union (EU) GMP certificates followed audits of the company’s Charleston manufacturing and lab operations for parenteral products and its Wilmington inspection, labeling, packaging, shipping and lab operations supporting Charleston.
CEO Pat Walsh said earning these EU GMP Certificates lets their global clients know they will have no issues shipping pharmaceuticals from these facilities into Europe, or into countries such as Canada and Australia that have mutual recognition agreements (MRAs) with the EU.