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20-04-2016

FDA inspection in Inke with no observations in April 2016

Inke’s manufacturing plant passed its latest US FDA (US Food and Drug Administration) inspection by mid-April. The inspection resulted in no “Form 483” (no observations were noted).

The inspection was carried out by the FDA inspection service from April 11 to 15, 2016 and covered cGMP (current Good Manufacturing Practices)

Inke, the Invent Farma Group company specialised in the manufacture of active pharmaceutical ingredients (APIs), meets cGMP standards and has a successful track record of inspections, including the inspections that the company periodically receives from the US FDA in its plant located in Castellbisbal near Barcelona in Spain, since 2002. For Inke, this has been its fifth FDA inspection successfully passed.

This achievement of Inke comes on top of the good results obtained, in less than one year, with regard to inspections carried out by the FDA to companies of the Invent Farma Group, since Laboratorios Lesvi, the company of the group specialised in the manufacture of generic pharmaceutical specialities, obtained a favourable report after its first FDA inspection in September 2015.

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