The inspection was done by the representatives of the FDA, EMA from the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Products Agency of Sweden (MPA).
As part of the inspection, Pii’s clients received EMA marketing authorization for a soft gel product and re-authorization for a tablet product.
The FDA has conducted a separated inspection to evaluate the company’s quality systems as a follow up to its December 2010 inspection for four Pre Approval Inspections.
Pii senior vice president Steve Kin said this approval allows Pii to continue providing commercial manufacturing services to the global pharmaceutical industry.
"We look forward to working with our clients to bring several other products to market," Kin said.