Darmerica, LLC - 716152 - 12/08/2025

Regulatory 90/100Rated 90/100Source typeRegulator or clinical registryIndependent sourcesstill being verifiedEvery claim links to the page it came from, and stronger sources rate higher. Full methodology →
December 8, 2025↗ source

FDA warned API supplier Darmerica, LLC (Davie, FL) after a March 2025 inspection found CGMP failures that render its drug APIs adulterated, plus misbranding violations including distribution of APIs ineligible for 503A compounding. The letter specifically cites the firm's drug listing for Hexarelin Acetate (NDC 71052-621), which reported an incorrect active peptide ingredient. It ties the misbranding to products distributed for compounding use.

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