# FDA 483 - Greiner Bio-One GmbH - October 25, 2018

Source: https://www.keypedia.com/records/483/greiner-bio-one-gmbh/bd41752a-4081-45d9-b7e8-c9c5ea3cbfed

> FDA 483 for Greiner Bio-One GmbH on October 25, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greiner Bio-One GmbH
- Inspection Date: 2018-10-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Greiner Bio-One GmbH, a medical device manufacturer in Kremsmuenster, Austria, received a Form 483 with seven observations. The inspection revealed significant deficiencies in design control, process validation, corrective and preventive actions, medical device reporting, complaint handling, change control documentation, and supplier control. These issues indicate a broad lack of established and implemented quality system procedures.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-a-humbard/4b57c427-30a9-4965-8dd2-eba6f3a50536)
- [Melanie W. Pishnery](https://www.keypedia.com/people/melanie-w-pishnery/ff4846b0-ffe1-4df0-9116-4bb238866b3a)

Company: https://www.keypedia.com/companies/greiner-bio-one-gmbh/3eeba95c-99e8-4ab8-8478-7dbc994a4970

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