# FDA 483 - Sklar BOV Solutions, Inc. - May 23, 2025

Source: https://www.keypedia.com/records/483/sklar-bov-solutions-inc/084806dd-6395-4235-bfb9-f6b3664ee26d

> FDA 483 for Sklar BOV Solutions, Inc. on May 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sklar BOV Solutions, Inc.
- Inspection Date: 2025-05-23
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Sklar BOV Solutions, Inc. in Statesville, NC, a drug manufacturer, was inspected and received seven observations related to significant deficiencies in their quality system. The inspection revealed failures in equipment cleaning validation, water system controls, process validation, raw material identity testing, equipment qualification, adherence to written procedures, and annual product reviews. These issues indicate a lack of robust controls to ensure drug product quality and consistency.

## Related Documents

- [483 - 2018-03-07](https://www.keypedia.com/records/483/sklar-bov-solutions-inc/09afc1fc-b48f-41c5-b4f6-c9762ba2f9fa)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [investigator](https://www.keypedia.com/people/tammy-t-brown/d83095ba-80a1-4006-b429-d8c0d49fcd2b)

Company: https://www.keypedia.com/companies/sklar-bov-solutions-inc/bb3c6506-3c30-482d-86a7-4f421dba8efa

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