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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.