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Custom Research Labs Inc. manufactured adulterated drug products, including hand sanitizers, that failed to comply with current good manufacturing practice (CGMP) regulations. FDA inspectors found that the company did not adequately test incoming components such as active pharmaceutical ingredients (camphor and menthol) and deionized water for identity, purity, strength, and quality, nor did it validate or establish the reliability of supplier test analyses at appropriate intervals, as required by 21 CFR 211.84(d). The hand sanitizer products were also marketed as unapproved new drugs and misbranded in violation of the Federal Food, Drug, and Cosmetic Act. The inspection occurred June 1-4, 2021, at the company's Gardena, California facility.