# FDA 483 - Bing Innovations Llc - October 17, 2023

Source: https://www.keypedia.com/records/483/bing-innovations-llc/c645e512-2542-4281-b999-ea11126f17e2

> FDA 483 for Bing Innovations Llc on October 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bing Innovations Llc
- Inspection Date: 2023-10-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: This FDA Form 483 report details severe quality system deficiencies observed at Bing Innovations Llc in Boca Raton, FL, during an inspection from October 11-17, 2023. The firm was cited for a complete lack of established procedures across multiple critical areas, including management representation, training, CAPA, complaint handling, purchasing controls, and quality audits. These findings indicate a fundamental absence of a functional quality system, posing significant risks to product quality and regulatory compliance.

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.keypedia.com/companies/bing-innovations-llc/a1e16794-bffc-4044-baf2-3d6eeaf57842

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6