# FDA 483 - Sac, Llc - August 27, 2024

Source: https://www.globalkeysolutions.net/records/483/sac-llc/1344ae42-c800-4bec-ac23-6ed9593e740a

> FDA 483 for Sac, Llc on August 27, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sac, Llc
- Inspection Date: 2024-08-27
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Sac, Llc, a medical device manufacturer in Sanford, FL, was inspected by the FDA from August 21-27, 2024. The inspection revealed significant deficiencies across multiple quality system areas, including complaint handling, corrective and preventive actions, nonconforming product control, document control, incoming product acceptance, and training. These observations indicate a systemic lack of adequately established and followed procedures.

## Related Officers

- [Brandon P. Thompson](https://www.globalkeysolutions.net/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)

Company: https://www.globalkeysolutions.net/companies/sac-llc/d202e01b-fe4b-4a54-8173-81c6aaa59bd5

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