# FDA 483 - Galbraith Laboratories Inc - March 02, 2022

Source: https://www.globalkeysolutions.net/records/483/galbraith-laboratories-inc/67d2319b-7e82-4720-b800-0978b4a88632

> FDA 483 for Galbraith Laboratories Inc on March 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Galbraith Laboratories Inc
- Inspection Date: 2022-03-02
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Galbraith Laboratories Inc, a control testing laboratory in Knoxville, TN, revealed significant deficiencies in their quality systems. The firm failed to perform routine inspections and audit trail reviews for electronic equipment, and their quality control unit lacked the authority to properly investigate errors and oversee the CAPA system. These issues indicate a need for improved adherence to written procedures and quality assurance practices.

## Related Documents

- [483 - 2023-11-16](https://www.globalkeysolutions.net/records/483/galbraith-laboratories-inc/041a6eb6-c541-4c83-af78-47857aaa75c1)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)
- [Pharmaceutical Specialist/ Investigator ](https://www.globalkeysolutions.net/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.globalkeysolutions.net/companies/galbraith-laboratories-inc/6a269a6c-2d54-487f-93d9-8939dc052c2d

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