# FDA 483 - Edwards Lifesciences, LLC - April 11, 2014

Source: https://www.globalkeysolutions.net/records/483/edwards-lifesciences-llc/90c28218-fc3d-4614-b3e6-832c8f27015e

> FDA 483 for Edwards Lifesciences, LLC on April 11, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edwards Lifesciences, LLC
- Inspection Date: 2014-04-11
- Product Type: device
- Office Name: Denver District Office
- Summary: Edwards Lifesciences, LLC, a medical device manufacturer in Draper, UT, was cited for numerous quality system deficiencies during an FDA inspection. The inspection revealed significant issues with process validation, corrective and preventive actions, production process monitoring, and control of nonconforming products. These findings indicate a systemic lack of adequately established procedures across critical manufacturing and quality control areas.

## Related Documents

- [483 - 2014-04-11](https://www.globalkeysolutions.net/records/483/edwards-lifesciences-llc/5c53d14c-7897-4588-bb69-53c328fa8494)

## Related Officers

- [Amanda S. Zorn](https://www.globalkeysolutions.net/people/amanda-s-zorn/b633fc9d-b511-45ed-a5ac-8b764420352c)
- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)
- [Sean T. Creighton](https://www.globalkeysolutions.net/people/sean-t-creighton/80ffecab-0a2d-4727-a11f-407b697f4503)
- [Investigator](https://www.globalkeysolutions.net/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.globalkeysolutions.net/companies/edwards-lifesciences-llc/33cf0071-5dab-4e01-8479-22f60c63e818

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face