FDA 483 - Allure Labs, Inc. - November 23, 2020

Allure Labs, Inc. in Hayward, CA, was inspected and cited for significant deficiencies across multiple systems. The inspection revealed failures in equipment cleaning validation and procedures, inadequate finished product testing for active ingredients, and a lack of stability data for product expiration dates. Additionally, the firm lacked scientifically sound sampling plans, written production and process controls, complete batch production records, and proper raw material identity testing and supplier validation.