# Milliken Healthcare Products, LLC – FDA 483, Jul 30, 2026

Source: https://www.keypedia.com/records/483/milliken-healthcare-products-llc/3e60420f-cca5-4482-980d-5bef8b27b3d5

> FDA 483 for Milliken Healthcare Products, LLC on July 30, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Milliken Healthcare Products, LLC
- Inspection Date: 2026-07-30
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Milliken Healthcare Products, LLC in Spartanburg, SC, a manufacturer, revealed a significant issue with their corrective and preventive action (CAPA) system. The firm failed to adequately address the root cause of compromised stability samples, which were critical for verifying product efficacy, and did not initiate a new CAPA to prevent recurrence. This indicates a breakdown in their quality system regarding nonconformity resolution.

## Related Officers

- [Benjamin E. Bowen](https://www.keypedia.com/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.keypedia.com/companies/milliken-healthcare-products-llc/19e411c0-54c1-45e2-853f-24f21eeacf78

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7