FDAfs January 15 Warning Letter issued to McNeil Consumer Healthcare (division of Johnson and Johnson) cites the company at several levels for failure to follow GMPs:
a. Failure to perform a timely and thorough investigation of numerous complaints of a bad odor in its Tylenol and Motrin products;
b. Failure of the companyfs QC group to follow through on the investigation;
c. Failure to file a timely Field Alert Report, and corporate J+J senior managementfs failure to ensure that timely thorough investigations were followed;
Attached please find a copy of the Warning Letter. As always such letters raise questions about whether any other company would have reacted differently, or in a more timely manner.