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Companies often see quality assurance (QA) as a small, obscure component of their cost of sales line --- an insurance premium.  However, occasionally QA takes flight as a "black swan" that can hurt the bottom line, or worse.  On April 24, 2009 P&G's CEO received a blistering 9-page warning letter from a frustrated FDA excoriating the quality control at its Puerto Rican plant and the manufacture of certain Olay [www.olay.com] and Vicks [www.vicks.com/products/sinex-nasal-spray] products. The Cayey plant has a history of problems dating back to the 1978 national shelf recall of Vicks Sinex for contamination with Pseudomonas sp., a pathogenic water-borne bacterium responsible for problematic skin and mucus membrane infections, for example hot tub folliculitis.  Many of the details of the current situation are disclosed in a "sanitized" FDA redaction [link]

Adulterated products include:  Sinex Long Acting Nasal Spray, Olay Total Effects Revitalizing Daily Foam, Regenerist Micro Sculpting Cream, Moisture Face Wash, Moisture Rich Cream Cleanser; also cited was Vicks Early Defense Hand Sanitizer.

Many OTC health and beauty care products are only dispensed once by the consumer so the preservative systems are not repeatedly challenged.  However, Sinex and Olay products depend on the user recontacting the product in ways that can either add to, or take away, bacteria.  Preservative systems are designed to maintain shelf stability and resist normal challenge by typical organisms.  These products demand a robust system.

Although the offending organisms are not disclosed they are said to be gram positive bacteria; these include Pseudomonas and a variety of pathogenic gut organisms.  Given contamination of metal tanks and fillers Pseudomonas is highly likely since it forms tenacious biofilms hard to disinfect or remove.  These organisms, if they enter the respiratory system, can cause pneumonia, particularly in compromised patients with cystic fibrosis.  Exposed skin can develop folliculitis and necrosis.  Worse many strains are drug-resistant and stubborn to treat; sepsis can result.

The FDA inspected the facility in mid-to-late 2008 prompting a P&G response to its findings.  A warning letter is only issued if the response is found inadequate.  P&G now has 15 working days to respond or face further actions that could include plant closure, product recall, or seizure.  Plant audits and closures can cause collateral damage to brands manufactured in the same plant or on the same line as is the case here.

Audit findings that were not resolved satisfactorily include:  poor sanitation, filth, bacterial contamination, SOP failures, sloppy procedures, and a broken consumer complaint handling system.  First, P&G offered a losing defense, often offered as an excuse after a site audit, that a product's preservative system would protect against product adulteration at the plant [i.e. - its OK to shoot someone if he's wearing a bulletproof vest].  Second, they used flimsy technical rationales, i.e.-paper arguments, to ship some products in question.  Third, to guarantee the timing of their ship dates to the trade they shipped product before concluding product validation, a temptation much to be resisted.  Further, they ignored prior consumer complaints and their own internal observations of a precipitate in Sinex related to its preservative system.  Moreover, they then tried to eliminate the problem by reducing the preservative level thereby reducing both the offending precipitate and its theoretical anti-bacterial efficacy.  Ironically, Vicks Early Defense Hand Sanitizer was also shipped without validation but later removed voluntarily from the market.

All of these FDA observations suggest an over eagerness to satisfy the trade at the expensive of the consumer.  P&G does indeed need to clean its house.

Donald K. Riker, Ph.D.
Dr. Riker is the President & Founder, On Point Advisors, LLC, a healthcare consultancy, and Editor-in-Chief, OTC Product News dedicated to the over-the-counter healthcare industry. He is the former Vice President R&D & Chief Scientific Officer, Chattem, Inc. and Associate Director & Fellow, Personal Healthcare, Procter & Gamble. Dr. Riker is an elected member of several medical and scientific organizations, The Licensing Executive Society, and the Association of Healthcare Journalists.

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