Fagron BV
FDA issued a warning letter to Fagron BV (operating as Fresenius Kabi Compounding, LLC / Fagron Sterile Services in Canton, MA), a registered 503B outsourcing facility, following an October–November 2025 inspection that revealed serious sterility assurance deficiencies in the production of sterile drug products. Investigators found that operators blocked first-air to sterile vials, smoke studies were inadequate, environmental monitoring was insufficient, and the quality unit failed to act on known adverse trends involving defective IV bags — all causing drug products to be adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B). The facility had already initiated a voluntary recall in February 2026 of affected lots, but FDA found multiple corrective action responses inadequate or unsupported by documentation. FDA warned that failure to adequately address violations may result in seizure or injunction.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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