FDA 483 - Cardinal Health 414, LLC - March 18, 2026

Between March 15 and March 18, 2026, the FDA inspected Cardinal Health 414, LLC, a Positron Emission Tomography (PET) drug manufacturing facility located in Jackson, Mississippi. The inspection resulted in the issuance of a Form 483, which highlighted significant deficiencies in the maintenance and repair of critical manufacturing equipment. Specifically, investigators observed that a "hot cell" used for the aseptic manipulation of PET drug products was in a state of disrepair. The interior lead-shielded glass of the hot cell door was broken and missing sections at the corners, and the firm had failed to conduct a risk assessment to determine the impact of this damage on the identity, strength, or purity of the drugs. Additionally, rust and chipped paint were found on the hinges and surfaces of the equipment, posing a direct contamination risk. Despite these conditions, the facility had manufactured and released approximately hundreds of batches of PET drug injections over the preceding 12 months. These findings were reported under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. The firm is expected to address these observations by discussing corrective actions with the FDA or submitting a formal written response detailing their remediation plan to the agency"s Nashville District office.