FDA Inspection
BNX Converting, LLCBNX Converting, LLC – FDA Inspection, May 7, 2026
Record Details
This FDA Inspection record concerns BNX Converting, LLC, with an inspection on May 7, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 5d6fe5b6-4b87-4831-ba2c-d9bc1deb7328
Inspection Facts
- Inspection number
- 1315944
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 4.1.6QMS software not validated prior to use or changes
- ISO 13485:2016 Clause 4.2.3Medical device file does not contain specific requirements
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.9Records of design and development changes and their reviews not maintained
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
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