# FDA 483 - Heraeus Medical Components LLC FKA Evergreen Medical - April 26, 2019

Source: https://www.globalkeysolutions.net/records/483/heraeus-medical-components-llc-fka-evergreen-medical/a28e2d6c-5b41-4f07-8074-9ac33e1f5d2f

> FDA 483 for Heraeus Medical Components LLC FKA Evergreen Medical on April 26, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Heraeus Medical Components LLC FKA Evergreen Medical
- Inspection Date: 2019-04-26
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Heraeus Medical Components LLC FKA Evergreen Medical, a medical device manufacturer in Saint Paul, MN, identified two significant issues. The firm failed to adequately validate a critical manufacturing process and did not properly document corrective and preventive action activities, including root cause and corrective actions for a customer complaint.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/susan-m-matthias/cd23c465-4411-4988-8676-2089e265622a)

Company: https://www.globalkeysolutions.net/companies/heraeus-medical-components-llc-fka-evergreen-medical/53c43114-a281-4315-9834-8eb041375ebb

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d