Dayton, Ohio-based Vienna Beauty Products draws a warning letter from FDA for inspection findings that render its Triple Lanolin Aloe Vera Foot Scrub adulterated under federal food and drug law. Testing of the product turned up microbial contamination, with sample aerobic plate counts significantly above FDA-established levels for non-eye-area products, according to the letter posted July 27. “Of particular concern,” FDA says, was the presence of pathogens Pseudomonas aeruginosa and Burkholderia multivorans/B. cepacia group. Also during the inspection, conducted in late 2011, the agency identified insanitary conditions and inadequate quality-control measures to protect against product contamination. Vienna’s November response to the inspection findings was insufficient in that it did not include detailed information on proposed corrective actions. The firm has 15 days to respond to FDA’s warning.
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