Globepharm Consulting ‚ÌGMPŠÖ˜A‹Æ–±‚Ì‚²ˆÄ“à


FDA's January 15 Warning Letter


FDAfs 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 companyfs QC group to follow through on the investigation;
c. Failure to file a timely Field Alert Report, and corporate J+J senior managementfs 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.








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