Pliva submits corrective plan in response to FDA warning letter

By Lisa Kerner

Erie, Pa., May 8 - Pliva d.d. said it has received a warning letter from the Food and Drug Administration regarding the inspection of its manufacturing facility in Zagreb, Croatia.

As a result, Pliva management submitted to the FDA a corrective action plan, which the FDA accepted.

Pliva said it is implementing this plan and is working closely with external expert consultants.

The company said it will continue to supply approved active pharmaceutical ingredients and finished dosage forms while it takes corrective action.

Pliva is a Zagreb, Croatia-based pharmaceutical company.

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