# FDA 483 - National Biological Corp - March 13, 2020

Source: https://www.globalkeysolutions.net/records/483/national-biological-corp/7e195170-89aa-41fe-9aa6-903e34acc746

> FDA 483 for National Biological Corp on March 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: National Biological Corp
- Inspection Date: 2020-03-13
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of National Biological Corp in Beachwood, OH, a medical device manufacturer, identified five significant quality system deficiencies. The firm lacked adequate procedures for in-process product acceptance, process parameter monitoring, risk analysis, supplier management, and design change controls. These findings indicate a systemic failure to establish and adhere to robust quality processes, potentially impacting product quality and safety.

## Related Documents

- [WARNING_LETTER - 2017-03-20](https://www.globalkeysolutions.net/records/warning_letter/national-biological-corp/73e3630e-9dcd-4460-b5e2-e88faffc0e15)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.globalkeysolutions.net/companies/national-biological-corp/2ea6c746-7d5e-43ca-bc6f-ced3c21c9311

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22