FDA 483 - NeuroField, Inc. - December 05, 2022

An FDA inspection of Lashify, Inc., a cosmetic repacker/relabeler, took place from November 14 to December 5, 2022. The inspection revealed several significant issues, indicating that the company's cosmetic products may be adulterated under Section 601(c) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations included the absence of written procedures for cleaning and maintaining equipment, specifically tweezers used in assembling false eyelashes. Additionally, employees on the production line were observed not wearing proper protective attire, such as hairnets or beard covers, raising concerns about potential product contamination. A critical finding was the lack of a written procedure for handling customer complaints, despite documented reports of adverse events like eye irritation and allergic reactions from consumers, which were not investigated. Notably, issues related to equipment cleaning, employee attire, and complaint management were identified as repeat observations from a prior inspection in 2018. Lashify, Inc. must address these deficiencies to ensure product safety and regulatory compliance.