# FDA 483 - Technicuff Corp. - April 24, 2024

Source: https://www.keypedia.com/records/483/technicuff-corp/33e21c62-096a-4c4b-9e78-1a1daf72ad58

> FDA 483 for Technicuff Corp. on April 24, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Technicuff Corp.
- Inspection Date: 2024-04-24
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Technicuff Corp. in Leesburg, FL, a medical device manufacturer, was inspected by the FDA from April 22-24, 2024. The inspection revealed five observations related to inadequate quality system procedures, including issues with nonconforming product control, statistical techniques for product acceptance, management representation, document control, and purchasing controls. Several violations were noted as repeat issues, indicating significant deficiencies in their quality management system.

## Related Officers

- [Ulysses D. Singleton](https://www.keypedia.com/people/ulysses-d-singleton/e62f9da3-2c82-4ad7-910d-2da18144c789)

Company: https://www.keypedia.com/companies/technicuff-corp/c942089a-b176-4f8b-bbed-cc58b57d065d

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