# FDA 483 - Datascope Corp. - June 15, 2023

Source: https://www.keypedia.com/records/483/datascope-corp/d32c9b5b-eb44-4fe0-bce5-319a9a920249

> FDA 483 for Datascope Corp. on June 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Datascope Corp.
- Inspection Date: 2023-06-15
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Datascope Corp. in Wayne, NJ, was inspected and cited for significant deficiencies in its quality system, particularly concerning corrective and preventive actions, non-conforming product control, and medical device reporting. The firm failed to properly manage supplier corrective actions, evaluate non-conforming materials in a timely manner, and submit required initial and supplemental Medical Device Reports within regulatory timelines, with some issues linked to patient death and serious injury. This inspection highlights systemic issues in quality management and regulatory compliance.

## Related Documents

- [483 - 2022-01-21](https://www.keypedia.com/records/483/datascope-corp/4f9e1108-301d-4fd0-8ee1-8d64ab2aa49d)
- [483 - 2025-08-21](https://www.keypedia.com/records/483/datascope-corp/473e9503-a2f9-4391-904a-f0fad32c41dd)

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/datascope-corp/93b4afd8-759e-4b70-9257-998288b4752a

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