# FDA 483 - MRP, LLC dba Aquabiliti - February 27, 2020

Source: https://www.globalkeysolutions.net/records/483/mrp-llc-dba-aquabiliti/90574e3f-9c8d-466b-9a91-8762d630cba5

> FDA 483 for MRP, LLC dba Aquabiliti on February 27, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MRP, LLC dba Aquabiliti
- Inspection Date: 2020-02-27
- Product Type: other
- Office Name: New Orleans District Office
- Summary: MRP, LLC in Nashville, TN, a medical device manufacturer, was inspected by the FDA from February 18-27, 2020. The inspection revealed three significant observations related to inadequate design verification, deficiencies in corrective and preventive action procedures, and a lack of valid statistical rationale for stability studies. These issues indicate a need for improved quality system controls, particularly in product design and process validation.

## Related Documents

- [483 - 2022-10-18](https://www.globalkeysolutions.net/records/483/mrp-llc-dba-aquabiliti/c990fd1d-4c46-4e4f-9044-05609656a633)

## Related Officers

- [Mary A. Millner](https://www.globalkeysolutions.net/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.globalkeysolutions.net/companies/mrp-llc-dba-aquabiliti/f96d032d-ca2d-4610-ad28-28231b305167

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea