FDA WARNING_LETTER - Petaware LLC - January 22, 2014

The FDA issued a Warning Letter to Petaware following a January 8-22, 2014 inspection of their Miami, Florida facility, and a review of product labeling and website content. The letter addresses violations concerning the firm's powdered tear stain remover products containing tylosin tartrate, a macrolide antibiotic. The FDA determined that several products, including Pets' Spark, Glow Groom, and Health Glow, are unapproved new animal drugs under sections 201(g)(1) and 201(v) of the FD&C Act. Lacking required FDA approval, these products are considered unsafe and adulterated under sections 512(a) and 501(a)(5). Additionally, exported tear stain remover products like Sparkle Eyes and Clean Eyes contain tylosin tartrate, an unapproved food additive, rendering them adulterated under section 402(a)(2)(C)(i). Furthermore, exported drug products (Pets' Spark Vegetarian, Glow Groom, Health Glow) are misbranded under section 502(e)(1)(A) because their labels omit the established name or quantity of the active ingredient. Similarly, exported food products (Sparkle Eyes, Clean Eyes) are misbranded under section 403(i) for failing to list all ingredients. Petaware's previous responses regarding GMP compliance were inadequate, failing to address the approval status and tylosin tartrate use. The firm must respond within fifteen working days, outlining corrective actions and providing documentation, or face potential enforcement actions like product seizure or injunction.