FDA WARNING_LETTER - World Perfumes Inc. - May 09, 2025

The FDA issued a Warning Letter to World Perfumes Inc. on October 29, 2025, following an inspection of their Opa-Locka, FL drug manufacturing facility from May 5 to 9, 2025. The letter highlights significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), deeming their drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

A primary issue was the company"s failure to conduct adequate identity testing for drug product components. Specifically, World Perfumes Inc. did not test incoming ethanol for dangerous methanol contamination, nor did they ensure the alcohol met United States Pharmacopoeia (USP) specifications, even using non-pharmaceutical grade ethanol. The letter emphasizes the global lethal poisoning incidents linked to methanol-contaminated ethanol. Furthermore, the company failed to properly test high-risk ingredients, such as glycerin, for Diethylene Glycol (DEG) or Ethylene Glycol (EG) contamination, which also have a history of causing fatal poisonings.

The FDA found the company"s responses to these observations inadequate, lacking sufficient detail on how future testing would meet regulatory requirements or address the impact on products already on the market.

World Perfumes Inc. is required to undertake comprehensive actions, including an independent review of their material system, supplier qualification, and incoming material controls. They must establish robust chemical quality control specifications and detailed procedures for testing each component lot for identity, strength, quality, and purity. Critical commitments include providing methanol, DEG, and EG test results for retain samples of all components or finished drug products within 30 days.