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Homeopathic Product for Infants Contaminated with Bacteria and Cancer-Causing Lubricant
An eleven-day FDA inspection in early 2023 of a contract manufacturer of homeopathic and over-the-counter (OTC) drug products, including those intended for infants and children, revealed serious lapses in the firm’s manufacturing, deviation, laboratory, and complaint investigation systems. This is an analysis of that Denison Pharmaceuticals 483, which turned into a Warning Letter. The […]
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