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Omeza LLC, a drug manufacturer in Sarasota, Florida, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter pain and itch relief products, including Omeza Lidocaine Lavage and Omeza Skin Protectant. During an FDA inspection in July 2023, investigators found that the company failed to maintain clean and sanitary manufacturing facilities, documenting mold-like substances on air conditioning equipment directly above drug manufacturing areas and potential rodent, bird, insect, and pest infestation issues. The products were deemed adulterated due to non-conforming manufacturing methods, facilities, and controls, and were also classified as unapproved new drugs introduced into interstate commerce in violation of federal law.