# FDA 483 - Gulbrandsen Technologies Inc - February 16, 2022

Source: https://www.globalkeysolutions.net/records/483/gulbrandsen-technologies-inc/6a409285-53e8-438d-9ce8-679f930bc141

> FDA 483 for Gulbrandsen Technologies Inc on February 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gulbrandsen Technologies Inc
- Inspection Date: 2022-02-16
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Gulbrandsen Technologies Inc. in Orangeburg, SC, an API manufacturer, received a Form 483 with three observations. The inspection revealed a lack of written procedures for equipment cleaning and maintenance, deficiencies in laboratory notebook record-keeping, and inadequate controls to ensure the originality and integrity of release testing data.

## Related Officers

- [Bryan L. Mcguckin](https://www.globalkeysolutions.net/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.globalkeysolutions.net/companies/gulbrandsen-technologies-inc/1a94e52e-c026-4b40-8cfd-66ea3c4ba645

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