FDA 483 - Sani-Care Salon Products, Inc - November 03, 2023

Sani-Care Salon Products, Inc., an OTC drug manufacturer, received an FDA Form 483 following an inspection conducted from October 31 to November 3, 2023. The inspection revealed significant deficiencies primarily related to quality control, production, laboratory operations, materials management, and packaging/labeling.A key observation was the complete absence of a quality control unit with documented procedures and sufficient authority, indicating a fundamental lack of a quality management system. The company also failed to validate critical manufacturing processes, including those for their ForPro Instant Hand Sanitizer, equipment cleaning, and the water system used in drug production. Batch records were found deficient, lacking essential documentation like equipment identification and personnel verification.Laboratory controls were also inadequate, with no established finished product specifications or active ingredient testing prior to release. The firm relied solely on supplier Certificates of Analysis for raw materials without performing identity testing or validating supplier data, and even utilized expired raw materials. Furthermore, no stability studies were conducted to determine expiration dates for their drug products.These observations highlight the company's non-compliance with Good Manufacturing Practices for over-the-counter drug products. Sani-Care Salon Products, Inc. is required to implement comprehensive corrective actions to address these systemic issues, ensuring product identity, strength, quality, and purity, as mandated by the Federal Food, Drug, and Cosmetic Act.