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Sklar Personal Care Inc. was found to be manufacturing adulterated OTC drug products due to significant Current Good Manufacturing Practice (CGMP) violations at its North Carolina facility during a May-June 2025 inspection. The company failed to conduct required identity testing on incoming raw material components before using them in drug manufacturing, with particular concern raised regarding untested raw materials that could be contaminated with methanol—a substance linked to lethal poisoning incidents in other contexts. Without adequate incoming component testing, the firm lacked scientific evidence that raw materials met appropriate specifications before incorporation into finished drug products, directly violating 21 CFR 211.84(d)(1).