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Talk to a SpecialistTalk to a SpecialistGenlabs Corporation, a drug manufacturer in Chino, California, was cited for significant current good manufacturing practice (CGMP) violations that rendered their finished pharmaceutical products adulterated, including over-the-counter hand soaps and dishwashing concentrate. The FDA inspection conducted in November-December 2021 identified failures to establish and follow adequate written procedures for cleaning and maintenance of equipment, particularly problematic because the company manufactured both pharmaceutical products and non-pharmaceutical industrial products using the same equipment without proper controls. The company's December 2021 response to the FDA Form 483 was deemed inadequate due to insufficient detail and evidence of corrective actions needed to achieve compliance. Additionally, the FIRST STREET Dishwashing Concentrate & Antimicrobial Hand Soap product was found to be misbranded under federal law.