# FDA 483 - Molecular Ms Diagnostics, LLC - April 16, 2024

Source: https://www.keypedia.com/records/483/molecular-ms-diagnostics-llc/ecbd4794-a51e-4039-8455-2812585e552c

> FDA 483 for Molecular Ms Diagnostics, LLC on April 16, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Molecular Ms Diagnostics, LLC
- Inspection Date: 2024-04-16
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: During an inspection conducted by the Food and Drug Administration (FDA) from April 8 to April 16, 2024, at Molecular Ms Diagnostics, LLC, a contract test laboratory located in Warwick, RI, two significant observations were noted. The primary issue involved insufficient controls over computer systems, posing a risk to data integrity. The firm's data acquisition software, utilized for various analytical tests including high-performance liquid chromatography and gas chromatography, lacked proper security measures. All analysts shared the same username and password and possessed administrative privileges, enabling potential unauthorized deletion or alteration of raw data files. One system notably lacked both user login and audit trail capabilities. Additionally, the inspection identified deficiencies in equipment maintenance. Critical temperature-controlling units, used for storing chemicals and reagents for marketed drug products, had not undergone periodic requalification since July 2019 and October 2020, respectively. Furthermore, a performance qualification for one refrigerator was incomplete, omitting essential open-door recovery and power-loss simulation studies. These observations highlight areas where Molecular Ms Diagnostics, LLC must implement corrective actions to ensure compliance with regulatory standards governing data integrity and equipment validation in a testing laboratory environment. The company is expected to respond to these findings with plans for remediation.

## Related Documents

- [483 - 2024-04-16](https://www.keypedia.com/records/483/molecular-ms-diagnostics-llc/87604ebf-3413-4859-a720-709184a0670e)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/mark-w-jackson/d4c56fee-b58d-4f39-aa7a-996f86282cc3)

Company: https://www.keypedia.com/companies/molecular-ms-diagnostics-llc/9db0d5d9-b881-4bca-857a-c9549c863d83

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516