Private Label Skin Care, Inc. Warning Letter Details

Summary

Private Label Skin Care, Inc. was warned for manufacturing over-the-counter drug products in violation of Current Good Manufacturing Practice (CGMP) regulations, rendering their products adulterated. The FDA inspection from June 16-23, 2025 identified significant violations including failure to establish an adequate quality control unit and failure to submit drug listings for at least 21 human OTC drugs to the FDA's electronic Drug Registration and Listing System as required by law. These unlisted drugs were deemed misbranded and their introduction into interstate commerce was prohibited. The company's manufacturing methods, facilities, and controls did not conform to required pharmaceutical standards.