BNX Converting, LLC – FDA 483, May 7, 2026
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.
ID · acda4fad-f40b-4b14-bf16-125d123404fc
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