# BNX Converting, LLC – FDA 483, May 7, 2026

Source: https://www.keypedia.com/records/483/bnx-converting-llc/acda4fad-f40b-4b14-bf16-125d123404fc

> FDA 483 for BNX Converting, LLC on May 07, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BNX Converting, LLC
- Inspection Date: 2026-05-07
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: BNX Converting, LLC, a manufacturer of Class II N95 Respirators in Houston, TX, was cited for significant deficiencies across its quality management system. The inspection revealed failures in maintaining design change records, validating manufacturing processes and equipment, and adequately incorporating post-market feedback into risk management. Additionally, the firm failed to comply with UDI labeling and GUDID registration requirements and did not validate its quality management system software.

## Related Officers

- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/bnx-converting-llc/3b680da1-4ecb-4ccc-87fe-cf0e4bf2968d

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab