PLIVA Successfully completes FDA Inspection

PLIVA has successfully completed site inspection done by FDA on February, 2015.  PLIVA’s Production process is regularly inspected by regulatory agencies. PLIVA is the only FDA approved manufacturer of active pharmaceutical ingredient and finished dosage form in Croatia, Europe.  FDA has inspected the process and procedure at PLIVA manufacturing site to establish that the product manufactured at the site comply with Good Manufacturing Practices.  Inspection covered the production of active pharmaceutical ingredient, oral dosage form, semisolid and sterile drug product. Inspection was completed in February and no observations were found by FDA inspector. This inspection of FDA confirmed PLIVA’s compliance with GMP and other standard relevant for pharmaceutical industry.