# FDA 483 - Grimm Scientific Industries - June 16, 2023

Source: https://www.globalkeysolutions.net/records/483/grimm-scientific-industries/96b6dc17-e263-49fa-9bb0-5d9f7d8cfe68

> FDA 483 for Grimm Scientific Industries on June 16, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grimm Scientific Industries
- Inspection Date: 2023-06-16
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: Grimm Scientific Industries in Marietta, OH, underwent an FDA inspection from June 13-16, 2023, which identified significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm's CAPA subsystem allowed unauthorized access and modification of records, lacked adequate documentation for validation testing, and failed to generate CAPAs for complaints. These issues indicate a critical breakdown in the firm's quality management system regarding corrective and preventive actions.

## Related Documents

- [WARNING_LETTER - 2012-03-02](https://www.globalkeysolutions.net/records/warning_letter/grimm-scientific-industries/9861c58d-b020-41e5-ba1e-e10118cd662c)

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/grimm-scientific-industries/52ae95e4-d02b-49fa-8850-ffa7f20fcf8c

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