Company violated numerous regs
By James Limbach, ConsumerAffairs.com
St. Louis-based Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have agreed to stop the illegal manufacture, marketing, and distribution of over-the-counter antimicrobial drugs used to treat and prevent infection.
The Food and Drug Administration (FDA) says its inspectors found that Care-Tech violated numerous provisions of the agency's current good manufacturing practice (cGMP) regulations that direct how antimicrobial drugs are made.
Additionally, it says the products do not conform to any applicable regulations for OTC drug products and have not undergone an FDA review, and therefore are considered unapproved drug products.
Under the terms of a consent decree, Care-Tech may not resume manufacturing and distribution of the drugs until it corrects these and other violations.
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