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Talk to a SpecialistTalk to a SpecialistChemical Services Group, Inc./Royal Chemical Company was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter hand sanitizer drug products at their Pennsylvania facility. The company failed to establish adequate written procedures for equipment cleaning and maintenance, and critically, manufactured pharmaceutical products on the same equipment used for non-pharmaceutical chemicals including industrial cleaners, polymers, and paint additives, creating unacceptable cross-contamination risks. Additionally, the firm left drug component and bulk drug product transfer pipes open to the outside environment without proper cleaning procedures or safeguards for external storage tanks. The company's response to the FDA's initial inspection findings was deemed inadequate for failing to provide sufficient detail or evidence of corrective actions necessary to achieve CGMP compliance.