# FDA 483 - Grace Analytical Lab Inc - September 29, 2021

Source: https://www.keypedia.com/records/483/grace-analytical-lab-inc/2010f89f-ad36-4c71-ad82-faf99648d509

> FDA 483 for Grace Analytical Lab Inc on September 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grace Analytical Lab Inc
- Inspection Date: 2021-09-29
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Grace Analytical Lab Inc, a control testing lab in Berkeley, IL, was cited for significant deficiencies across its quality control unit, laboratory records, computer system controls, and personnel. The inspection revealed issues including data integrity concerns with backdated entries, lack of qualified QA personnel, unvalidated systems, and insufficient employee training in GMP. These findings indicate a systemic failure to adhere to good manufacturing practices.

## Related Documents

- [483 - 2019-05-30](https://www.keypedia.com/records/483/grace-analytical-lab-inc/0ee1af49-c82a-4638-bc2d-3edf5b763258)
- [WARNING_LETTER - 2019-05-30](https://www.keypedia.com/records/warning_letter/grace-analytical-lab-inc/700b1758-6e9b-41ce-9f35-975c8a048da9)

## Related Officers

- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)

Company: https://www.keypedia.com/companies/grace-analytical-lab-inc/14addad3-9191-4571-bd60-0e95acc967fd

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669