# FDA 483 - ROMD, LLC - February 11, 2020

Source: https://www.keypedia.com/records/483/romd-llc/fb756ab8-b5cb-4ed4-b96f-f51313ec82e6

> FDA 483 for ROMD, LLC on February 11, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ROMD, LLC
- Inspection Date: 2020-02-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of ROMD, LLC in Rochester Hills, MI, a medical device establishment, revealed three significant observations. The firm failed to adequately establish procedures for complaint handling and MDR determination, design change, and ensuring purchased products and services conform to requirements. These deficiencies indicate a lack of robust quality system controls.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/romd-llc/9ad223a0-cb6d-467f-8fff-eea204b390cf

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0