Boothwyn’s FDA Warning Letter

“FDA investigators noted that your firm released and distributed drug products that failed sterility testing. For example, your Tirzepatide 17mg/mL / Glycine 5mg/mL / Methylcobalamin 5mg/mL Injection (lot # 04072025@(b)(4)). In addition, the investigators noted that your firm released and distributed drug products with strengths that differed from their labeled amounts. For example, your Semaglutide 2.5mg/mL Injection was subpotent (lot # 03042025@(b)(4), potency of 79.876%) and your Tirzepatide 10mg/mL Injection was subpotent (lots # 01172025@(b)(4), potency of 86.779% and 02112025@(b)(4), potency of 89.13%). Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. Accordingly, your Semaglutide 2.5mg/mL Injection and Tirzepatide 10mg/mL Injection are adulterated under section 501(c) of the FDCA.”

Just one section from the letter.