FDA WARNING_LETTER - Estar Technologies Ltd - April 01, 2026

On April 22, 2026, the FDA issued a Warning Letter to Estar Technologies Ltd after determining that the firm is distributing several medical devices without required marketing clearance or approval. The products in question include various Tropocells kits (PRP, PRF, TRS, PRFM), TropoVisc, Tropokine, and Cellenis PRP kits. The central issue identified during the FDA"s review of the company"s websites is the promotion of these devices for unauthorized medical uses. Specifically, while the Tropocells PRP kit had limited clearance for use in bone graft procedures, the company marketed it for a wide array of unapproved applications, including the treatment of musculoskeletal injuries, osteoarthritis, wound healing, and ophthalmology. Under the Federal Food, Drug, and Cosmetic Act, these major changes to the products" intended use require new safety and effectiveness reviews by the agency. Without these, the devices are considered legally adulterated and misbranded. The FDA has directed Estar Technologies to cease all activities leading to these violations, including the commercial distribution of the devices for unapproved uses. The company is required to submit a written response within 15 business days outlining the specific actions taken to correct the violations and a strategy to prevent them from recurring. Failure to address these concerns promptly may result in regulatory enforcement, such as product seizures, legal injunctions, or civil penalties.