FDA WARNING_LETTER - Froggy’s Fog LLC - September 15, 2021

On April 14, 2022, the FDA issued a Warning Letter to Froggy’s Fog LLC following a September 15, 2021 inspection of their drug manufacturing facility. The letter cited significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211) for finished pharmaceuticals, rendering their drug products adulterated. Additionally, their "SIMPLY 70 HAND SANITIZER GEL (70% Alcohol)" product was deemed misbranded.

Key violations included: 1. **Failure to establish written procedures for production and process control (21 CFR 211.100(a))**: The firm lacked adequate process and water system validation protocols/studies, and batch records omitted process parameters/in-process specifications. Their response was inadequate, failing to demonstrate reproducible manufacturing or address risks from shared equipment. 2. **Failure to perform adequate laboratory testing prior to release (21 CFR 211.165(a) and (b))**: Hand sanitizer batch records lacked microbiological and impurity testing. Finished product strength testing relied on an unsuitable density meter. FDA testing revealed "SIMPLY 70" contained only 61% ethanol v/v, not the labeled 70%. The firm's corrective actions were deemed incomplete. 3. **Failure to establish adequate laboratory controls (21 CFR 21