# FDA 483 - SC Johnson Professional USA, Inc. - October 30, 2018

Source: https://www.keypedia.com/records/483/sc-johnson-professional-usa-inc/4d42c68b-5a21-4bc6-b23a-c3556c37b9b9

> FDA 483 for SC Johnson Professional USA, Inc. on October 30, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SC Johnson Professional USA, Inc.
- Inspection Date: 2018-10-30
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: The FDA inspected Deb USA Inc. in Stanley, NC, a drug manufacturer, from October 22-30, 2018, and issued nine observations. The inspection revealed significant deficiencies in quality control, laboratory practices, and equipment design, particularly concerning microbiological testing, data integrity, and water systems. Several issues were repeat observations from previous inspections, indicating systemic failures to ensure product quality and compliance with established procedures and regulations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/rachael-l-cook/294a8276-4e31-4d9f-8f2d-6c8f08cefd06)
- [Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/adam-r-cooke/337c005d-e9dc-4512-aadb-ee0b0c637bd5)

Company: https://www.keypedia.com/companies/sc-johnson-professional-usa-inc/e9b50d00-3095-4f01-9e05-4f21adc9812a

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