FDA WARNING_LETTER - Jabil, Inc. - March 06, 2026

On August 27, 2026, the FDA issued a warning letter to Jabil Inc. following an inspection of its subsidiary facility, Pharmaceutics International, Inc., in Cockeysville, Maryland. The inspection, conducted between February 23 and March 6, 2026, identified critical violations of Current Good Manufacturing Practice (CGMP) standards for sterile drug production. Main issues included the company"s failure to thoroughly investigate sterility failures and recurring mold contamination in sterile filling areas. The FDA found that the firm often closed investigations without identifying root causes or implementing effective corrective actions. Additionally, the Quality Control Unit demonstrated inadequate oversight, evidenced by the failure to document hundreds of manual interventions during the filling process and the use of flawed disinfectant studies. Physical facility maintenance was also deficient, with peeling paint and debris found in classified manufacturing environments. These failures categorize the firm"s drug products as adulterated under the Federal Food, Drug, and Cosmetic Act. To address these violations, the FDA requires Jabil Inc. to engage an independent consultant to conduct a comprehensive audit of their manufacturing systems. Required actions include performing a thorough risk assessment of contamination hazards, remediating aseptic processing designs, and providing a detailed plan to ensure robust quality unit oversight. The company must submit a written response outlining their corrective measures within 15 business days.