FDA 483 - Alkaline Corp. - September 06, 2024

Alkaline Corp. in Eatontown, NJ, was inspected regarding its manufacturing of drug products, specifically hand sanitizers. The inspection revealed significant deficiencies across its quality system, including the absence of a quality control unit, inadequate component testing, lack of stability data, and incomplete batch records. These issues indicate a severe lack of adherence to Good Manufacturing Practices.