Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSkyless, LLC, a drug manufacturer in Puerto Rico, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated products. During a May 2022 inspection, the FDA identified critical violations including the company's failure to perform appropriate laboratory testing and batch conformance determinations prior to product release, as required by 21 CFR 211.165(a). Additionally, three topical pain relief products marketed under the X-PASMO brand were found to be unapproved new drugs introduced into interstate commerce in violation of FD&C Act section 505(a), and were misbranded under sections 502(ee) and 502(c).