Omeza LLC

Warning LetterOpen

Ms. Cynthia Flowers Chief Executive Officer Omeza LLC 1610 Northgate Boulevard Sarasota , FL 34234 United States (b)(6), (b)(7)(C)FEI 3019843904Issued Dec 12, 2023Office of Pharmaceutical Quality

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Letter Details

Firm: Omeza LLC
Location: Ms. Cynthia Flowers Chief Executive Officer Omeza LLC 1610 Northgate Boulevard Sarasota , FL 34234 United States (b)(6), (b)(7)(C)
FEI Number: 3019843904
Country: United States
Issue Date: December 12, 2023
Issuing Office: Office of Pharmaceutical Quality
Product Type: Drugs
Status: Open

Summary

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.