Froggy’s Fog LLC

Warning LetterOpen

Mr. Adam Pogue Owner and Chief Executive Officer Froggy’s Fog LLC 1536 North Main Street Mount Pleasant , TN 38474 United StatesFEI 3013443567Issued Apr 14, 2022Office of Pharmaceutical Quality Operations, Division II

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Violations6

Issue DateApr 14, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Froggy’s Fog LLC
Location: Mr. Adam Pogue Owner and Chief Executive Officer Froggy’s Fog LLC 1536 North Main Street Mount Pleasant , TN 38474 United States
FEI Number: 3013443567
Country: United States
Issue Date: April 14, 2022
Issuing Office: Office of Pharmaceutical Quality Operations, Division II
Product Type: Drugs
Status: Open

Summary

Froggy's Fog LLC was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of SIMPLY 70 HAND SANITIZER GEL and other drug products, rendering them adulterated and misbranded. The company failed to establish written procedures for production and process control, lacked adequate process validation and water system validation protocols, and did not include process parameters or in-process specifications in batch records to demonstrate control over manufacturing. The FDA inspection conducted on September 15, 2021 identified these deficiencies, and despite the company's October 2021 response indicating plans to develop validation protocols, the violations were serious enough to prohibit introduction of the products into interstate commerce.

Froggy’s Fog LLC FDA Warning Letter, April 14, 2022