Honest Globe, Inc.
3605 West Macarthur Boulevard, Suite 701
Santa Ana , CA 92704-6845
United StatesFEI 3015667771Issued Mar 15, 2021Division of Pharmaceutical Quality Operations IV
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 3015667771.
Violations11
Issue DateMar 15, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Honest Globe, Inc.
Location
Honest Globe, Inc.
3605 West Macarthur Boulevard, Suite 701
Santa Ana , CA 92704-6845
United States
FEI Number
3015667771
Country
United States
Issue Date
March 15, 2021
Issuing Office
Division of Pharmaceutical Quality Operations IV
Product Type
Drugs
Status
Open
Summary
Honest Globe, Inc. was warned for manufacturing adulterated drug products in violation of current good manufacturing practice (CGMP) regulations, specifically for their ELIXICURE PAIN RELIEF with CBD topical products (roll-on and pump versions) sold without FDA approval. The company's CBD-containing products were unapproved new drugs marketed without a new drug application and were misbranded under the Federal Food, Drug, and Cosmetic Act, as no nonprescription CBD-containing drug has received FDA approval for legal marketing. The violations were identified during an FDA inspection of their Santa Ana, California facility conducted October 4-8, 2019, and the company's manufacturing methods, facilities, and controls for producing these finished pharmaceuticals failed to meet CGMP standards.
Honest Globe, Inc. FDA Warning Letter, March 15, 2021