In a recent Warning Letter, the FDA outlines severe GMP deficiencies in the manufacture of OTC hand sanitizers and antibacterial soaps, including missing identity testing, lack of stability data, and absent process validation. Critical raw materials such as glycerin and ethanol were accepted without proper testing – despite their known risk of contamination with diethylene glycol (DEG), ethylene glycol (EG), or methanol, substances that have caused fatal poisoning incidents worldwide.
