# King Brand Healthcare Products – FDA 483, Jul 24, 2026

Source: https://www.keypedia.com/records/483/king-brand-healthcare-products/3db43615-d744-48ce-8df6-2824913ec22d

> FDA 483 for King Brand Healthcare Products on July 24, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: King Brand Healthcare Products
- Inspection Date: 2026-07-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of King Brand Healthcare Products in Bellingham, WA, revealed significant deficiencies in their medical device quality system. The firm failed to adequately submit Medical Device Reports for devices experiencing serious malfunctions, lacked proper Unique Device Identification documentation, and did not maintain required design and development files or perform adequate design validation. Additionally, the company lacked written quality agreements for outsourced processes and failed to maintain equipment maintenance records, indicating systemic issues with their quality management.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/king-brand-healthcare-products/8b99e453-0250-483c-be2d-cec40b684aea

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822