FDA 483 - Allure Labs, Inc. - March 27, 2026

Allure Labs, LLC, a manufacturer located in Hayward, California, underwent an FDA inspection from March 23 to March 27, 2026. The inspection identified several critical deficiencies within the firm"s quality and laboratory systems, particularly regarding the production of over-the-counter (OTC) non-sterile drug products. A primary concern was the company"s failure to adequately investigate batches that failed to meet quality specifications. Instead of identifying a root cause for these failures, the firm adjusted its release standards without scientific justification or process re-validation, allowing non-compliant products to enter commerce. Additionally, the FDA noted significant gaps in data integrity and computer system controls. The firm failed to review electronic audit trails for microbial and purity testing software, a repeat violation from 2021. This lack of oversight means the company cannot guarantee that electronic records have not been altered or deleted. Furthermore, the company"s microbial testing methods were deemed inadequate, as they relied on a qualitative system that could not provide required numerical counts or identify specific harmful organisms. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, these observations indicate potential non-compliance with safety standards. Allure Labs is required to respond to the FDA with a detailed plan for corrective actions or submit objections to the findings to ensure their manufacturing processes meet industry requirements.