# FDA 483 - Datascope Corp. - October 03, 2018

Source: https://www.keypedia.com/records/483/datascope-corp/4a39d3c0-ea28-468b-b852-4334a028b7c9

> FDA 483 for Datascope Corp. on October 03, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Datascope Corp.
- Inspection Date: 2018-10-03
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Datascope Corp. in Mahwah, NJ, a manufacturer of Cardiosave Intra-Aortic Balloon Pumps, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included failures in establishing and executing procedures for design validation, design change, design verification, corrective and preventive actions, supplier management, and maintaining adequate device history records. The firm also failed to ensure proper review and approval of documents.

## Related Documents

- [WARNING_LETTER - 2018-10-03](https://www.keypedia.com/records/warning_letter/datascope-corp/130a38e2-99ed-4c36-be89-7fcce4413760)

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)
- [Melissa Zuppe](https://www.keypedia.com/people/melissa-zuppe/e34e3943-0e3c-4a24-983d-6ac8aa2cc906)

Company: https://www.keypedia.com/companies/datascope-corp/fb84709f-8911-4733-99a2-fa448d2f6272

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