FDA 483 - Allure Labs, Inc. - December 03, 2021

Allure Labs, Inc. in Hayward, CA, was cited for significant deficiencies during an FDA inspection. Observations included a failure to fully follow quality control procedures, inadequate microbiological testing of OTC drug products and water, and issues with data integrity in computer systems. Additionally, the firm lacked proper written procedures and logs for sanitation in the dispensing area.