# FDA 483 - THEWEB2U.COM, LLC - July 30, 2019

Source: https://www.keypedia.com/records/483/theweb2ucom-llc/556c21c9-d496-4d99-89a0-da02190d3a3e

> FDA 483 for THEWEB2U.COM, LLC on July 30, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: THEWEB2U.COM, LLC
- Inspection Date: 2019-07-30
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The Web 2U Com LLC, a medical device specification developer, repacker, and relabeler in Fort Lauderdale, FL, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to establish and adequately maintain procedures for critical areas such as design control, document control, acceptance activities, purchasing controls, medical device reporting, device master records, statistical techniques, and device history records. These observations indicate a systemic lack of compliance with regulatory requirements for medical device manufacturing and quality management.

## Related Documents

- [483 - 2023-01-23](https://www.keypedia.com/records/483/theweb2ucom-llc/ffc9075c-3342-4de2-b4f2-1f24c10dffb4)

## Related Officers

- [Dianiris C. Ayala](https://www.keypedia.com/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)

Company: https://www.keypedia.com/companies/theweb2ucom-llc/4d5a006e-7da6-496b-a0a6-09ef3a381006

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