FDA WARNING_LETTER - Maison Terre, LLC - April 01, 2021

The FDA issued a Warning Letter to Ms. Brown of (b)(6) on April 1, 2021, following testing of "Goldenseal Root Powder Organic" repackaged at her facility. The product was found to be adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the FD&C Act due to insanitary conditions and non-compliance with Current Good Manufacturing Practice (CGMP) requirements.

Specifically, the facility, which shared space with residential living and food production, operated in a residential kitchen and temporarily in a living room, lacking controls to prevent contamination. FDA testing revealed "Goldenseal Root Powder Organic" contained over 260,000 cfu/g of total aerobic microbial growth, over 5,000 cfu/g of total yeast and mold, and objectionable microorganisms like Enterobacter cloacae, Klebsiella pneumoniae, and Cronobacter sakazakii, posing an intolerable risk, especially for use on broken skin. An infant death was associated with its use. The company initiated a voluntary recall on August 17, 2020, and committed to ceasing production.

CGMP violations included failure to conduct appropriate laboratory testing for microbial attributes (21 CFR 211.165(b)), failure to test incoming components for microbiological contamination (21 CFR 211.