# FDA 483 - Greiner Bio-One North America, Inc. - December 13, 2019

Source: https://www.globalkeysolutions.net/records/483/greiner-bio-one-north-america-inc/ad34488d-2369-44a6-b972-117854ce1696

> FDA 483 for Greiner Bio-One North America, Inc. on December 13, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greiner Bio-One North America, Inc.
- Inspection Date: 2019-12-13
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Greiner Bio-One North America, Inc. in Monroe, NC, a medical device manufacturer, revealed nine significant quality system deficiencies. These included inadequate design validation for the VACUETTE product line, failure to process all medical device complaints, and unsubmitted MDR reports for serious injuries. The firm also demonstrated ineffective corrective actions, unvalidated manufacturing processes, and non-conforming finished device acceptance procedures, indicating systemic issues in regulatory compliance.

## Related Documents

- [WARNING_LETTER - 2019-12-13](https://www.globalkeysolutions.net/records/warning_letter/greiner-bio-one-north-america-inc/848b37fb-a03b-41e1-ad3a-e115f7d9eaf5)
- [483 - 2021-10-29](https://www.globalkeysolutions.net/records/483/greiner-bio-one-north-america-inc/d4c755b6-4e0b-4e58-b9c7-77a8b9ec9342)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-a-humbard/4b57c427-30a9-4965-8dd2-eba6f3a50536)
- [issuing_officer](https://www.globalkeysolutions.net/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)
- [Edward E. Lockwood](https://www.globalkeysolutions.net/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.globalkeysolutions.net/companies/greiner-bio-one-north-america-inc/5aa9ea16-ad85-4f85-9b30-efc0ae9b36de

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7