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| Courtesy of Ameriderm |
The FDA has come down on a New Jersey over-the-counter maker of lotions, creams and other dermatology products, including sanitizing gel. The problem, the agency claims, is that the Ameriderm Laboratories plant in Paterson, NJ, was not testing the water used in its OTC products to see if it was sterile. When the FDA performed the test, they found that it indeed wasn't. In fact, they found microorganisms including Pseudomonas aeruginosa, Cronobacter sakazakii, Burkholderia pseudomallei and Acinetobacter ursingii, according to a warning letter the FDA posted this week. There were 5 other issues, like the absence of a laboratory for testing containers and closures and the lack of written procedures on how to investigate when deviations from standard operating procedures occur. Warning letter