# FDA 483 - VENOKA USA INC - April 25, 2025

Source: https://www.keypedia.com/records/483/venoka-usa-inc/adf58073-cef0-41f1-8636-a2c77d371dda

> FDA 483 for VENOKA USA INC on April 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VENOKA USA INC
- Inspection Date: 2025-04-25
- Product Type: device
- Office Name: Florida District Office
- Summary: VENOKA USA INC, an importer/distributor in Tampa, FL, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm lacks established written procedures for critical processes including complaint handling, corrective and preventive actions, and Medical Device Reporting. These observations indicate a fundamental absence of essential quality control documentation and processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/venoka-usa-inc/d994397d-55d1-4180-972c-7f8c103469b3

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9