Loading…
Auto-Chlor System LLC, a drug manufacturer of over-the-counter hand sanitizer products including "Hand Kleen Foaming Instant Hand Sanitizer," failed to establish and follow written procedures for equipment cleaning and maintenance in violation of Current Good Manufacturing Practice (CGMP) regulations. The facility's manufacturing methods, facilities, and controls did not conform to CGMP standards, rendering the drug products adulterated, and the company's hand sanitizer product was introduced into interstate commerce as an unapproved new drug in violation of federal law. The FDA's August 2022 inspection of the Hapeville, Georgia facility identified significant violations, and the company's subsequent response to the inspection findings was deemed inadequate for demonstrating corrective actions needed to achieve compliance.