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On April 28, the US Food and Drug Administration's Center for Drug Evaluation and Research (Rockville, MD) issued a Warning Letter to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb, Croatia).
On April 28, the US Food and Drug Administration's Center for DrugEvaluation and Research (Rockville, MD, www.fda.gov/cder)issued a Warning Letter (www.fda.gov/cder/warn/2006/320-06-02.pdf)to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb,Croatia, www.pliva.com).The six-page letter, which FDA posted on May 5, refers to a variety ofshortcomings noted during inspections conducted Jan. 23 through Feb. 8,2006, as well as in August 2002:
In a May 8 statement, Pliva said that it was "addressing this issuevery seriously and is in the process of implementing a correctiveaction plan, which was submitted to the FDA in April and which, exceptas stated in the warning letter, has been accepted by the FDA."
According to the statement, Pliva does not expect any disruption indelivery of finished dosage forms and active pharmaceutical ingredientsto Pliva Inc. (its US subsidiary) or other customers. Though thecompany does anticipate that FDA will not approve any of Pliva'spending abbreviated new drug applications (ANDA) until the issues areresolved, the company "does not currently expect this to have anymaterial impact on the Company's financial outlook for 2006."