Novartis Gets 483 for Use of Down Bottle Bin

Novartis Pharmaceuticals has received a Form 483 noting a failure of its changeover inspection to ensure products from previous packaging operations are removed.

A customer complaint for the blood pressure medication Diovan HCT (valsartan/hydrochlorothiazide) reported finding tablets with the wrong dose of the drug in a sealed bottle, according to the form. During an inspection at the company’s Suffern, N.Y., facility, investigators concluded that inappropriate clearance of a down bottle bin from the previous run was one of the most likely root causes. The bin is used to hold filled bottles that had not been positioned correctly on the conveyer for labeling.

Novartis has implemented corrective actions and believes its responses and the actions fully address the observations, the company said.
Drug GMP Report