# FDA 483 - Abbott Molecular, Inc. - January 27, 2023

Source: https://www.globalkeysolutions.net/records/483/abbott-molecular-inc/0302de19-2fe8-4e87-a4ca-b74046f314e3

> FDA 483 for Abbott Molecular, Inc. on January 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott Molecular, Inc.
- Inspection Date: 2023-01-27
- Product Type: device
- Office Name: Chicago District Office
- Summary: Abbott Molecular, Inc. in Des Plaines, IL, was inspected from January 17-27, 2023, as a medical device manufacturer. The inspection revealed significant issues with the firm's corrective and preventive action (CAPA) procedures and documentation, specifically regarding supplier investigations. The firm failed to adequately establish procedures for effectiveness checks and did not accurately document implementation dates for corrective actions.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/abbott-molecular-inc/0efa8842-5f5e-4dd9-a381-edf99492a332

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669