# FDA 483 - Medicoplast International GmbH - April 22, 2022

Source: https://www.keypedia.com/records/483/medicoplast-international-gmbh/19109be8-eeb9-4750-b277-cfb223a7c27c

> FDA 483 for Medicoplast International GmbH on April 22, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medicoplast International GmbH
- Inspection Date: 2022-04-22
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Medicoplast International GmbH, a medical device contract sterilizer in Illingen, Germany, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in process validation, control of non-conforming product, corrective and preventive actions, and complaint handling procedures. These issues indicate a lack of robust quality system controls.

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/medicoplast-international-gmbh/f13de520-8e36-4485-af5a-d8d9e373cfbb

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4