Little Moon Essentials, LLC

Warning LetterOpen

Mr. William Richard Wilson Director of Operations Little Moon Essentials, LLC 501 Old Griffin Road Dania Beach , FL 33004 United States billy@littlemoonessentials.comFEI 3017366969Issued Sep 17, 2024Division of Pharmaceutical Quality Operations II

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017366969.

Violations7

Issue DateSep 17, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Little Moon Essentials, LLC
Location: Mr. William Richard Wilson Director of Operations Little Moon Essentials, LLC 501 Old Griffin Road Dania Beach , FL 33004 United States billy@littlemoonessentials.com
FEI Number: 3017366969
Country: United States
Issue Date: September 17, 2024
Issuing Office: Division of Pharmaceutical Quality Operations II
Product Type: Drugs
Status: Open

Summary

Little Moon Essentials, LLC was cited for manufacturing adulterated drug products in violation of Current Good Manufacturing Practice (CGMP) regulations at its Dania Beach, Florida facility during an inspection conducted January 16-18, 2024. The company's five topical analgesic products—including "Asana Kisser," "Ass Kisser," "Vital Vapor Balm," "Dream Cream," and "Magical Muscle Oil"—were determined to be unapproved new drugs introduced into interstate commerce without FDA approval and were misbranded under the Federal Food, Drug, and Cosmetic Act. The violations indicated that the company's manufacturing methods, facilities, and controls did not conform to required CGMP standards for finished pharmaceuticals.

Little Moon Essentials, LLC FDA Warning Letter, September 17, 2024