FDA WARNING_LETTER - Boothwyn Pharmacy LLC - June 09, 2025

The FDA issued a Warning Letter to Boothwyn Pharmacy, LLC on January 16, 2026, stemming from an inspection conducted between May 12 and June 9, 2025. This inspection identified serious deficiencies in the company's drug production practices, posing significant patient safety risks. The primary violations cited involve drug products that were found to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA).

Key issues included insanitary conditions during the production of sterile drug products, such as inadequate smoke studies for ISO 5 areas and the presence of difficult-to-clean or particle-generating surfaces. The FDA also found multiple drug products to be subpotent, including Fluorescein 2% Ophthalmic Solution, Semaglutide 2.5mg/mL Injection, and Tirzepatide 10mg/mL Injection. Additionally, a Tirzepatide injection lot failed sterility testing, and several products were misbranded due to inaccurate strength labeling.

While Boothwyn Pharmacy initiated a voluntary recall and temporarily halted GLP-1 sterile drug production, the FDA found the proposed corrective actions insufficient. Specifically, the company failed to provide adequate documentation for new smoke studies and cleanroom renovations. Concerns were also raised about contradictory internal procedures regarding the "at-risk" release of sterile products before final test results and the lack of a clear process for notifying patients about out-of-specification results. The FDA requires Boothwyn Pharmacy to take prompt action, submitting a detailed written response within 15 working days outlining comprehensive corrective measures, root cause analyses, and supporting documentation. The agency strongly recommends engaging a third-party consultant with expertise in sterile drug manufacturing to conduct a thorough assessment of all operations, particularly aseptic processing. Non-compliance may lead to further legal action.