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

Source: https://www.keypedia.com/records/483/cardinal-health-414-inc/e332ba0c-a10c-4c3c-8867-365f49900560

> FDA 483 for Cardinal Health 414, Inc. on June 13, 2025. Product: devices. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cardinal Health 414, Inc.
- Inspection Date: 2025-06-13
- Product Type: devices
- Office Name: Los Angeles District Office
- Summary: 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.

## Related Documents

- [483 - 2018-01-25](https://www.keypedia.com/records/483/cardinal-health-414-inc/9e267e16-1a0e-480e-a56a-aa94acef206a)
- [483 - 2020-02-25](https://www.keypedia.com/records/483/cardinal-health-414-inc/24f866a5-91a2-42f5-9723-bdd896f75653)
- [483 - 2025-06-13](https://www.keypedia.com/records/483/cardinal-health-414-inc/1bd29cd8-fa0c-4247-8d83-fde29b4de877)
- [483 - 2025-06-13](https://www.keypedia.com/records/483/cardinal-health-414-inc/1bc2a211-61a8-4a9e-8c97-4ec988cad06c)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Jason K. Loo](https://www.keypedia.com/people/jason-k-loo/7977c92f-c40e-45af-a072-f84361045a47)

Company: https://www.keypedia.com/companies/cardinal-health-414-inc/21a6534a-cb8f-4f96-9bec-43c254ea54bf

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b