FDA WARNING_LETTER - CelestaPro - November 01, 2025

On November 3, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to CelestaPro following a review of its website, www.celestapro.com. The FDA found that CelestaPro is illegally introducing unapproved and misbranded new drug products, specifically injectable botulinum toxin products like "Nabota 200 Unit," into interstate commerce. These products are considered unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they lack the required FDA approval for safety and effectiveness. They are also deemed misbranded as they are prescription drugs intended for conditions not amenable to self-diagnosis and treatment, yet their labeling does not bear adequate directions for a layperson"s safe use. The FDA highlighted significant risks associated with these unapproved and misbranded drugs, including potential contamination, counterfeiting, inconsistent active ingredients, and serious health hazards from injectables such as septicemia. CelestaPro is required to immediately cease offering these unapproved and misbranded drugs for sale to U.S. consumers. The company must also provide a written response to the FDA within 15 working days, detailing the specific corrective actions taken to address the violations and prevent their recurrence, along with supporting documentation. Failure to comply may lead to further legal action.