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Home » Cincinnati Sub-Zero Products Cited for FDCA, QS Violations
Cincinnati Sub-Zero Products Cited for FDCA, QS Violations
January 28, 2005
Cincinnati Sub-Zero Products was issued a warning letter by the FDA after an agency inspection revealed the company’s class II hypothermic/ hyperthermic machines to be adulterated within the meaning of Section 501(h) of the Federal Food, Drug and Cosmetic Act (FDCA) and for violations of the quality system (QS) regulation.