FDA Condemns P&G's Olay, Vicks and Sinex Factory as "Filthy"

Last Updated May 8, 2009 1:55 AM EDT

Procter & Gamble's Olay, Vicks and Sinex nasal spray OTC and pseudo-drug brands have been condemned as "filthy," "microbial," and "insanitary," by the FDA.

In a warning letter dated April 24, the FDA told P&G that an inspection of its Puerto Rico Olay factory revealed:
... that your OTC drug products have been prepared, packed and held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health, and are, therefore, adulterated
It was, apparently, not P&G's first brush with the FDA's wrath. The FDA wrote:
There is no assurance that the corrective action was effective in cleaning all the parts that showed microbial growth during the special sampling.
P&G responded that then company's:
finished product microbial content testing confirmed no recovery of the micro-organisms initially detected ...
But the FDA said:
We find this conclusion highly objectionable because the purpose of adding preservatives to drug and cosmetic products is not to kill microorganisms present in your finished products due to poor manufacturing practices, but rather to prevent the growth of microorganisms ...
The letter covers Sinex nasal spray and Vicks early defense hand sanitizer. The FDA concluded:
... your OTC drug products have been prepared, packed and held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health, and are, therefore, adulterated...
Side note: The FDA repeatedly refers to the P&G CEO as "Ag Lafley"; he is, of course, A.G. Lafley.

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