FDA WARNING_LETTER - INGENUE CARE - December 06, 2018

The FDA inspected Ingenue Care's drug manufacturing facility in Norwalk, CA, on multiple dates in late 2018, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The firm manufactures and distributes numerous products, including Lucidaroma Zeroma7 and various Lucid Aroma essential oils and roll-ons. These products are deemed unapproved new drugs, violating 21 U.S.C. 355(a), as they are marketed with therapeutic claims but lack FDA approval or compliance with OTC Monograph conditions. Additionally, several products are misbranded under 21 U.S.C. 352, specifically for lacking adequate directions for use (21 U.S.C. 352(f)(1)) for conditions requiring professional supervision, and Lucidaroma Zeroma7 for misleading labeling (21 U.S.C. 352(a)) regarding its dosage form. Key CGMP deficiencies include failure to perform finished product testing for identity, strength, and microbial attributes (21 CFR 211.165), inadequate component identity testing and supplier qualification (21 CFR 211.84), absence of an adequate stability testing program (21 CFR 211.166), and a lack of an established quality control unit with proper procedures and documentation (21 CFR 211.22). The FDA requires a written response within 15 working days detailing comprehensive corrective actions, including establishing procedures, validating methods, providing stability data, and implementing a robust quality system. A CGMP consultant is strongly recommended. Failure to comply may result in legal action, including product seizure, injunction, and denial of drug applications or export certificates.