# FDA 483 - Rowny Systems, Inc. - June 17, 2022

Source: https://www.keypedia.com/records/483/rowny-systems-inc/b664edde-2165-4f1a-8347-d9b79af51990

> FDA 483 for Rowny Systems, Inc. on June 17, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rowny Systems, Inc.
- Inspection Date: 2022-06-17
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Rowny Systems, Inc., a software manufacturer in Cabin John, MD, revealed significant deficiencies in its quality system. The firm failed to maintain device history records for its Antigen Plus product and lacked established procedures for device history records, design control, and quality audits. These findings indicate a fundamental lack of adherence to regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2019-09-17](https://www.keypedia.com/records/483/rowny-systems-inc/c8c445a2-50b1-47a4-81a6-a734e774ca2b)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/brandon-l-mariner/c1ff0e66-552d-466a-9b49-a083d0211c94)

Company: https://www.keypedia.com/companies/rowny-systems-inc/6d971e77-d191-4514-935e-d090f38c9faf

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64