# FDA 483 - GA Analytical LLC - January 16, 2013

Source: https://www.globalkeysolutions.net/records/483/ga-analytical-llc/9ba788cf-0f6d-4cd3-8394-364e92ecc7ea

> FDA 483 for GA Analytical LLC on January 16, 2013. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GA Analytical LLC
- Inspection Date: 2013-01-16
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of SA Analytical LLC's control laboratory in Mundelein, IL, revealed significant deficiencies in computer system controls and laboratory practices. The firm failed to ensure data integrity and proper user access for analytical software, and lacked adequate procedures for reviewing raw analytical data. Additionally, the inspection found issues with laboratory controls, including incomplete specifications for drug components and insufficient supplier qualification.

## Related Documents

- [483 - 2014-03-28](https://www.globalkeysolutions.net/records/483/ga-analytical-llc/2fcf84fe-6937-4c0a-a99c-b00938306f77)
- [483 - 2016-06-29](https://www.globalkeysolutions.net/records/483/ga-analytical-llc/f2152724-c02a-41eb-b68b-3548d82272b9)

## Related Officers

- [Compliance Officer at FDA](https://www.globalkeysolutions.net/people/christopher-d-leach/2a3c4b73-f082-4f33-aa2d-52d1abbb6d55)

Company: https://www.globalkeysolutions.net/companies/ga-analytical-llc/a655ac22-fdaa-4d52-ab76-0160f4787aa8

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