Olay's preservative defense
Inspectors found during August and November 2008 visits to an Olay manufacturing facility in Puerto Rico that over-the-counter drug products had been prepared, packed and held in unsanitary conditions "whereby they may have been contaminated with filth or rendered injurious to health," according to warning letter (SJN-2009-07) that followed in April 2009.
The company, a unit of Procter and Gamble, had detected gram negative bacilli initially and in the fourth-hour sample of a facial product. A retest confirmed these results, leading to a special sampling of product contact parts in the filling line.
The letter says that an Olay investigation concluded that poor practices of cleaning and sanitization led to the presence of bioburden. Technicians were not disassembling the filler for cleaning.
The FDA objected, however, to the company's lack of investigation into why the cleaning verification step was ineffective in identifying the problem and whether or not the current monitoring program is adequate to detect contamination.
The company responded that the corresponding finished-product microbial content testing confirmed no recovery of the microorganisms initially detected on the filling equipment monitoring samples. Olay maintains the problem was a low-level transient contamination killed off by the product preservatives system, according to the letter.
"We find this conclusion highly objectionable because the purpose of adding preservatives is not to kill microorganisms present in your finished products due to poor manufacturing practices," the regulators wrote, "but rather to prevent the growth of microorganisms in products manufactured in compliance with good manufacturing practices."