FDA Admonishes McNeil For Not Addressing Consumer Complaints

Posted on May 30, 2012

The Food and Drug Administration has some serious concerns about the safety procedures that a pharmaceutical giant has in place for handling complaints.

The McNeil division of Johnson & Johnson has been the recipient of a warning letter from the safety agency.  The FDA believes that this division failed to properly look into hundreds of consumer complaints on a series of products.  One product in particular, K-Y Liquibeads, reportedly elicited 227 complaints from June 2010 to December of last year.  Of these complaints, the FDA says that 100 were not vetted as completely as they should have been.  This either occurred because the company thought the complaints referred to nonexistent lot numbers or they simply failed to investigate or close the complaints without any justification as to why.

Also in regards to the Liquibeads, the FDA accuses McNeil of not testing the item to the extent required and not conducting a full evaluation of its storage needs or how long it might take for the item to go bad.

Aside from issues regarding Liquibeads, the FDA also takes McNeil to task for not reporting certain complaints within the 30 day window required by law.  One individual flossing with Reach reportedly lost a tooth and an O.B. Tampon user suffered Toxic Shock Syndrome, and neither of these things were reported in an expedited manner.

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