Turbare Manufacturing
FDA issued a warning letter to Turbare Manufacturing, a 503B outsourcing facility in Conway, Arkansas, following a January 2025 inspection that found serious sterile manufacturing deficiencies. The facility failed to conduct adequate process simulation (media fill) studies, investigate batch discrepancies, establish proper acceptance criteria for quality control, and maintain adequate environmental monitoring in aseptic processing areas. FDA found the drug products adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B), and the firm had already initiated a voluntary recall of Bevacizumab lots due to lack of sterility assurance; FDA warned that failure to adequately address violations may result in seizure and 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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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.
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