# FDA 483 - PACKAGE SOLUTIONS LLC - February 10, 2026

Source: https://www.keypedia.com/records/483/package-solutions-llc/5f5f7600-e458-4a73-ade5-dac18c64d196

> FDA 483 for PACKAGE SOLUTIONS LLC on February 10, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PACKAGE SOLUTIONS LLC
- Inspection Date: 2026-02-10
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: PACKAGE SOLUTIONS LLC, a manufacturer of personal lubricant devices in Pompano Beach, FL, was cited for significant deficiencies in its quality management system. The inspection revealed widespread failures in complaint handling, risk management, and documentation, indicating a lack of control over product quality and regulatory compliance. Repeat observations regarding the absence of Unique Device Identifiers (UDIs) on Class II devices highlight persistent non-compliance.

## Related Officers

- [Ebony D. Sanon](https://www.keypedia.com/people/ebony-d-sanon/703dc125-1019-43d1-9598-1bdc92026e2b)
- [Lorraine N. Williams](https://www.keypedia.com/people/lorraine-n-williams/f02f9092-4aa9-4def-9b9f-fca1c850cd00)

Company: https://www.keypedia.com/companies/package-solutions-llc/4c5134cb-29db-48fe-aeea-1d0ffc6a6266

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