GMP Stumble By Contract Manufacturer Trips Up Children’s Homeopathic Product Marketers

Warning letters sent earlier in August note GMP violations for contract manufacturer Denison Pharmaceuticals and customers CalmCo and ALVA-AMCO, which marketed children’s homeopathic products provided by Denison.

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Recent warnings to a contract manufacturer and two of its customers are reminders that the US Food and Drug Administration, since subjecting homeopathics to the same regulatory requirements as other types of drugs, is prioritizing products indicated for children in its inspections.

The agency on 15 August published warning letters noting good manufacturing practice regulations violations and sent earlier in the month to contract manufacturer Denison Pharmaceuticals LLC in Lincoln, RI, and two of its customers,

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