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Regulatory Focus™ > News Articles > Warning Letter to Company Cites Low Supplies of Toilet Paper

Warning Letter to Company Cites Low Supplies of Toilet Paper

Posted 15 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) sends warning letters to companies for many reasons, running the gamut of deficient manufacturing practices, false advertising, unapproved products and a myriad of other severe problems. But sometimes, as a warning letter sent this week shows us, a company just needs to make sure its employees have a fresh supply of toilet paper in a functioning bathroom.

In a warning letter to dietary supplement manufacturer Desert Rose Manufacturing on 1 March 2013, FDA said its investigators had observed a laundry list of violations during their July 2012 inspection of the company's New Mexico-based manufacturing facility.

The violations are not atypical for a warning letter sent to a supplement manufacturer, and include citations regarding the company's manufacturing operations, and in particular its recordkeeping, identity specifications, and finished-product specifications. FDA noted that these were repeat observations, some of which had been identified in at least two prior inspections.

Problem #2

But the manufacturing problems weren't the only thing that caught FDA's eye, and male workers at the company may be better off for the agency's observation.

Inspectors said the company "failed to keep paper towels and/or toilet tissue in the production area and the men's toilet in the production area did not flush." More than just a reason to gripe, FDA noted that the problem could potentially lead to the production area for the supplements becoming contaminated if staff were unable to properly clean their hands.

No similar issues were observed for the women's facilities, and the facility presumably had other bathrooms available for its staff since FDA identified the bathroom as the one in the "production area."

Per 21 CFR 111.15, companies are required to implement certain basic sanitary controls for their production facilities. Per 21 CFR 111.15(5), this can include making sure the grass around a facility is well-maintained, as a Warning Letter to dietary supplement manufacturer NatureMost in June 2012 warned.

In the case of Desert Rose Manufacturing, its violations were of 21 CFR 111.15(h), which mandates that companies "must provide [its] employees with adequate, readily accessible bathrooms…kept clean and must not be a potential source of contamination to components, dietary supplements or contact surfaces."

In other words, if you want to pass your inspection, better stock up on toilet tissue.

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