# FDA 483 - GETSCH+HILLER MEDIZINTECHNIK GmbH - July 21, 2022

Source: https://www.keypedia.com/records/483/getschhiller-medizintechnik-gmbh/ef5d4f8f-b10b-4890-9cf5-a80f5396abd2

> FDA 483 for GETSCH+HILLER MEDIZINTECHNIK GmbH on July 21, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: GETSCH+HILLER MEDIZINTECHNIK GmbH
- Inspection Date: 2022-07-21
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GETSCH+HILLER MEDIZINTECHNIK GmbH, a medical device manufacturer in Tuttlingen-Nendingen, Germany, revealed five significant quality system deficiencies. The firm failed to adequately establish complaint handling procedures, maintain a design history file, properly identify product acceptance status, conduct internal quality audits, and set quality objectives. These observations indicate a broad lack of compliance with medical device regulations.

## Related Documents

- [WARNING_LETTER - 2022-07-21](https://www.keypedia.com/records/warning_letter/getschhiller-medizintechnik-gmbh/bc570492-aa66-4108-a909-a1cf4455e3d9)

## Related Officers

- [Felix J. Marrero](https://www.keypedia.com/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.keypedia.com/companies/getschhiller-medizintechnik-gmbh/d572824c-30a5-4118-8d56-9c354287bcc0

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