# FDA 483 - VistaMed Ltd t/a Freudenberg Medical - November 16, 2016

Source: https://www.keypedia.com/records/483/vistamed-ltd-ta-freudenberg-medical/4878760d-3cd7-41fd-b5e7-6ec039f88bed

> FDA 483 for VistaMed Ltd t/a Freudenberg Medical on November 16, 2016. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: VistaMed Ltd t/a Freudenberg Medical
- Inspection Date: 2016-11-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Alstamed Ltd, a manufacturer of micro infusion catheters, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately control non-conforming products, releasing multiple lots of catheters despite documented visual, functional, and dimensional non-conformances. Additionally, the company did not document corrective and preventive action activities or results, even when critical effects and trends of non-conformities occurred.

## Related Documents

- [483 - 2025-04-03](https://www.keypedia.com/records/483/vistamed-ltd-ta-freudenberg-medical/0d2b32a8-82b7-4491-bbcd-35ea0cf853f2)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.keypedia.com/companies/vistamed-ltd-ta-freudenberg-medical/2d48b9ab-86ca-4179-a021-cf7a8d5359c5

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd