# FDA 483 - Froggy's Fog LLC - September 15, 2021

Source: https://www.keypedia.com/records/483/froggys-fog-llc/03e4e8a6-a0ba-4e03-ac1b-ed97c2413b0d

> FDA 483 for Froggy's Fog LLC on September 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Froggy's Fog LLC
- Inspection Date: 2021-09-15
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Froggy's Fog LLC, an OTC manufacturer in Mount Pleasant, TN, was cited for significant deficiencies in its quality control procedures. The inspection revealed a failure to validate critical manufacturing processes, equipment cleaning, and laboratory test methods for hand sanitizer drug products. These issues indicate a lack of assurance regarding consistent product quality and accurate testing.

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/froggys-fog-llc/426ddd40-f3e0-4e8b-8c34-0d722f36d442

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7