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FDA Warning Letter · #664245

Wwwgorillahealingcom — FDA Warning Letter (October 2, 2023)

Issued October 2, 2023Status: activeCenter for Drug Evaluation and Research (CDER)

Primary Source

View the original FDA letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wwwgorillahealingcom-664245-10022023

Summary

Company
Wwwgorillahealingcom
Letter number
#664245
Issue date
October 2, 2023
Subject
Compounded GLP-1 marketing and labeling concerns

What FDA cited

FDA cited the company in connection with the marketing and distribution of compounded GLP-1 products. See the linked FDA warning letter for the full text of the agency's concerns and the specific provisions of the Federal Food, Drug, and Cosmetic Act referenced.

What FDA warning letters mean

A warning letter is FDA's principal means of telling a company that the agency considers something it's doing — a marketing claim, a manufacturing practice, a labeling choice — to violate the Federal Food, Drug, and Cosmetic Act. Companies typically have 15 working days to respond.

A warning letter is not a recall, a criminal charge, or a finding that the company has broken the law. It is the start of a regulatory conversation. FDA may issue a close-out letter once it is satisfied that the company has corrected the cited issues.

For compounded GLP-1 telehealth providers, the most common citations involve unapproved new drug claims, misbranding, and the use of bulk drug substances not on FDA's approved list under FDCA sections 503A and 503B.

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Editorial Disclaimer

FDA warning letters are public regulatory communications and do not, on their own, indicate that a company has done anything illegal. Companies often respond to warning letters with corrective action, and many letters are eventually closed out. The full text of this letter is available on fda.gov via the link above.