FDA 483 - Fayetteville VA Medical Center - June 15, 2026

From June 8 to June 15, 2026, the FDA inspected the Fayetteville VA Medical Center in North Carolina, a producer of sterile drug products. This inspection, conducted under Section 704 of the Federal Food, Drug, and Cosmetic Act, identified several critical safety and sanitation violations that could compromise the quality of sterile medications.

Investigators found significant microbial contamination, including pathogenic fungi and bacteria, within an ISO Class 5 production area. The facility failed to follow its own internal policies by neglecting to investigate the source of this contamination or implement a corrective action plan. Furthermore, the inspection revealed poor cleaning and disinfection practices. Visible reddish-brown staining and residue were found on equipment used to prepare sterile drugs like Vancomycin and Infliximab. During a live observation, a technician failed to clean recessed equipment areas, leaving behind physical residue even after the cleaning process was finished.

A third major concern involved the high risk of drug cross-contamination. The facility produced both Beta-lactam and non-Beta-lactam drugs using the same equipment without performing necessary decontamination. The current cleaning procedures only required a superficial application of alcohol, which is insufficient to prevent potentially dangerous drug residues from mixing.

The FDA 483 form serves as a report of these observations and is not a final determination of compliance. The Fayetteville VA Medical Center is expected to respond to these findings by disputing the observations or, more critically, outlining a detailed plan of corrective actions to bring their operations into compliance with federal safety standards.