FDA Considers Further Regulatory Action Against McNeil

The FDA is reviewing serious findings in a post-inspection report for a McNeil Consumer Healthcare facility to determine if more regulatory action is warranted after a recent recall of OTC children’s products. The report cites numerous manufacturing deficiencies at the Fort Washington, Pa., facility, Deborah Autor, director of CDER’s Office of Compliance, said Tuesday. The most serious violations include failure to adequately investigate and correct problems, assure changes to manufacturing processes do not negatively impact the product and adequately maintain facilities.
Drug Industry Daily