FDA 483 - Cardinal Health 414, Inc. - June 13, 2025

An FDA inspection of Cardinal Health 414, Inc., located at 5030 1st Ave S Ste 110, from June 11 to June 13, 2025, resulted in the issuance of an FDA Form 483 to Site Supervisor Michele H. Dieterich. The primary observation cited a deficiency in the firm's written quality assurance procedures, specifically concerning the management of non-conformances.Inspectors noted that the company failed to establish a defined time limit between the observation of a deviation (non-conformance) and the initiation of its corresponding record. While a procedure for non-conformance investigation (SOP-01024) exists, it lacks a mandatory timeline for record initiation. Furthermore, the firm's documentation process does not effectively capture the date a non-conformance record is initiated, despite distinguishing it from the date the occurrence was identified. This was evident in examples where non-conformance events were identified several days before their records received the first attributable signature.These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicate a need for Cardinal Health to enhance its quality system. The company is expected to implement corrective actions, including establishing clear timelines for non-conformance documentation and revising its forms to accurately record the initiation date of such records, thereby ensuring a robust and timely quality management system.