FDA directs Procter & Gamble to address evidence of bacterial contamination in manufacturing Vicks cold-relief products in a facility in Puerto Rico.

In an inspection initiated in July 2008, FDA found P&G products at the plant in Cayey "have been prepared, packed and held under unsanitary conditions whereby they may have been contaminated with filth or rendered injurious to health," according to an April 24 warning letter.

FDA also cites Olay hair- and skin-care items.

P&G maintains it is working with FDA to resolve the concerns and that the safety of finished products in stores was not affected.

"The concerns by the FDA from their inspections were from inspections that they conducted in 2008 and they involve our manufacturing process and not the finished product in the marketplace," a P&G spokeswoman said May 6.

"Every batch of the products that are released from our plants pass through a strict quality and safety check and that allows us to have confidence that the products that we have in the marketplace are safe," she said.

Indeed, FDA's concerns largely center on processes within the facility rather than distributed goods, which are adulterated insofar as their production deviates from good manufacturing practices.

For example, P&G initiated an internal investigation in July 2008 and found certain manufacturing equipment at the plant contaminated with microbial growth. The company determined that poor cleaning and sanitation practices were the cause.

However, the company did not adequately address why the error went unnoticed initially, among other failings, FDA says.

OTC drug products manufactured at the plant were put at risk due to substandard sanitization practices, according to the letter.

Evidence of less-than-good manufacturing practices is visible in the company's treatment of "appearance failures" associated with its Vicks Sinex Long Acting Nasal Spray, according to the agency.

The appearance of a precipitate linked to the product's preservative system was not resolved by multiple changes made to the product's formulation and the company's manufacturing process, nor did the company validate those modifications, FDA notes.

"We find it highly objectionable that corrective actions identified in the technical justification report ... have not been validated or implemented."

P&G did not adequately address consumer complaints about the Vicks Sinex product, says the agency, which requests a complete evaluation of all associated consumer complaints and the firm's reasoning in determining that the "presence and level of this salt in your drug product does not represent a risk."

Products including Olay Total Effects Revitalizing Daily Foam, Olay Regenerist Micro Sculpting Cream, Olay Moisture Foaming Face Wash and Olay Moisture Rich Cream Cleanser also could have been affected by tainted equipment in the manufacturing process, FDA points out.

Nevertheless, P&G did not halt operations or take sufficient measures to guarantee the safety of products being released, according to FDA.

The plant manager responded to FDA's concerns in October, stressing that none of the microorganisms found on the filling equipment were detected in finished products, indicating that any contamination was at low levels or eliminated by the products' preservative systems.

FDA says it finds that argument "highly objectionable" because a product's preservative system is intended to keep it microbe-free while on store shelves, rather than to kill off contaminants introduced during the manufacturing process.

P&G has 15 working days from its April 29 receipt of the letter to notify FDA of specific steps taken to correct the violations.

P&G says it will make improvements in the manufacturing process at the Cayey facility. It underscores that FDA's concerns are only with the Puerto Rico site. The firm has six plants globally that manufacture the Vicks and Olay products FDA names in the warning letter.

- Molly Laas (m.laas@elsevier.com)

Evidence Of Bacterial Contamination At P&G Factory Draws Warning Letter

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