McNeil Consumer Healthcare Statement Regarding FDA Inspection Report

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 May 2010 - 12:00 PDT


We have no higher concern than providing parents with the highest quality products for their children. The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate. While the chance of serious adverse medical reaction is remote, we apologize to those who rely on our medicines for the concern and inconvenience this recall may have caused. We will provide a detailed response to the FDA on their observations, and work diligently to ensure that they are addressed.

We have temporarily suspended production at our Fort Washington, PA plant, where the observations were made. We will not restart operations until we have taken the necessary corrective actions and can assure the quality of products made there.

This step comes on top of others we already have taken to ensure quality compliance. Early this year we initiated a comprehensive assessment of quality and manufacturing systems across our operations. We have committed extensive internal resources to this effort, and brought in independent outside experts to assist us.

We will continue to work in close consultation with the FDA to take corrective action and ensure that our quality operations meet the high standards that consumers expect from us.

We remind consumers with questions about the recall of certain infants' and children's products to contact us here.

Source
Johnson & Johnson

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