Class Action Case against McNeil Consumer Healthcare, a division of Johnson & Johnson
Join the growing list of families that have been affected by McNeil’s over-the-counter children’s products.
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Inspectional Observations by the Department of Health and Human Services
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An inspection by the FDA of McNeil Consumer Healthcare's Fort Washington, PA plant found significant deficiencies with the firm's failure to adequately uncover and correct problems found in its manufacturing, and in its drugs. Here are just some of the Inspectional Observations by the division of Food and Drug Administration about McNeil Consumer Healthcare's Fort Washington, PA plant:
The responsibilities and procedures applicable to the quality control unit are not fully followed.
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Written production and process control procedures are not followed in the execution of production and process control functions.
Click here to read the full report.
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FDA Warning Letter to McNeil Consumer Healthcare
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In January 2010 The FDA issued WARNING LETTER SJN-2010-01 to McNeil Consumer Healthcare regarding its Las Piedras, Puerto Rico plant. The warning letter cites significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals which resulted in "uncharacteristic odor" complaints. These complaints were associated with reports of gastrointestinal distress for several McNeil OTC drug products.
Click here to read WARNING LETTER SJN-2010-01. |

