Maison Terre, LLC

Warning LetterOpen

Sarah A. Brown Owner Maison Terre, LLC (b)(6) (b)(6) , United States (b)(6).comIssued Apr 1, 2021Office of Pharmaceutical Quality Operations, Division II

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations6

Issue DateApr 1, 2021

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Maison Terre, LLC
Location: Sarah A. Brown Owner Maison Terre, LLC (b)(6) (b)(6) , United States (b)(6).com
FEI Number: N/A
Country: United States
Issue Date: April 01, 2021
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Food & Beverages
Status: Open

Summary

Maison Terre, LLC was warned for repackaging and distributing "Goldenseal Root Powder Organic" as an unapproved new drug under insanitary conditions that could contaminate the product with filth and render it injurious to health, in violation of Current Good Manufacturing Practice (CGMP) requirements. The FDA also identified several essential oil products (Orange Sweet Essential Oil and Ylang Ylang Essential Oil) sold on the company's website as unapproved new drugs and misbranded products. The facility shared drug manufacturing space with residential food production, contributing to the insanitary conditions violation.

Maison Terre, LLC FDA Warning Letter, April 1, 2021