# FDA 483 - Roche Molecular Systems, Inc. - December 08, 2023

Source: https://www.globalkeysolutions.net/records/483/roche-molecular-systems-inc/a25a7c49-4521-4b0a-813b-71436327812d

> FDA 483 for Roche Molecular Systems, Inc. on December 08, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roche Molecular Systems, Inc.
- Inspection Date: 2023-12-08
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Roche Molecular Systems, Inc. in Branchburg, NJ, received a Form 483 with two observations. The firm failed to report a biological product deviation for an IVD kit with internal control invalidations caused by a software error during the filling process. Additionally, the firm did not adequately evaluate a supplier, which resulted in numerous customer complaints about leaking reagent bottles.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)
- [investigator](https://www.globalkeysolutions.net/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)
- [Nisha C. Patel](https://www.globalkeysolutions.net/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)

Company: https://www.globalkeysolutions.net/companies/roche-molecular-systems-inc/603d5520-1c54-4282-88f0-76549211cf07

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248