Physician Therapeutics, LLC – FDA Warning Letter

The FDA issued a Warning Letter to William Shell, M.D., CEO of Physician Therapeutics, LLC, on April 8, 2010, based on information from an inspection of their contract manufacturer, (b)(4). Physician Therapeutics, LLC distributes several drug products, including "Theracodophen-650 Convenience Pack" and "Strazepam Convenience Pack," which are classified as "new drugs" under section 201(P) of the Act because they lack general recognition of safety and effectiveness. The firm does not possess FDA-approved applications for these products, violating sections 301(a), 301(d), and 505(a) of the Act. Furthermore, the products are misbranded under section 502(f)(1) of the Act and 21 C.F.R. § 201.5 due to inadequate directions for use, as they are not suitable for self-diagnosis. The products are also deemed adulterated under 21 U.S.C. § 351(a)(2)(B). Physician Therapeutics, LLC is responsible for investigating and correcting these violations promptly and preventing their recurrence. A written response detailing corrective actions and timelines is required within fifteen working days. Failure to comply may lead to legal actions such as seizure and injunction, and could affect future federal contracts.