FDA 483 - XeCare LLC - June 17, 2026

From June 8 to June 17, 2026, the Food and Drug Administration (FDA) conducted a series of inspections at XeCare LLC, a New Albany, Ohio-based producer of sterile and non-sterile drug products. The inspection, issued to Director Andrew T. Bruggeman, revealed several significant safety and quality control deficiencies under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act.

Key violations included the failure to provide adequate containment for hazardous drugs. Investigators found that shared equipment was cleaned between batches without the use of deactivating agents, increasing the risk of cross-contamination. Additionally, the facility"s hazardous drug weighing room failed to maintain required negative air pressure, with over 50 pressure alarm events recorded while production was active. The FDA also observed poor aseptic practices, specifically noting that sterile materials were exposed to lower-quality air during transfers into the sterile hood. Finally, the firm used untested water in the production of non-sterile gummy medications.

Although these observations do not constitute a final agency determination on compliance, XeCare LLC is expected to address these issues. The company should submit a formal response to the FDA detailing its planned or implemented corrective actions to ensure the facility meets the necessary standards for pharmaceutical safety and quality.