# FDA 483 - Edwards Lifesciences Technology SARL - June 11, 2019

Source: https://www.keypedia.com/records/483/edwards-lifesciences-technology-sarl/24a26b1b-925f-48b3-9007-78825c7bd44f

> FDA 483 for Edwards Lifesciences Technology SARL on June 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edwards Lifesciences Technology SARL
- Inspection Date: 2019-06-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Edwards Lifesciences Technology SARL in Anasco, PR, a medical device manufacturer, was cited for inadequate documentation of corrective and preventive action (CAPA) activities. The firm failed to adequately justify the bounding of a field action related to incorrect assembly of Swan Ganz thermodilution catheters and did not investigate the root cause of an identified equipment discrepancy. These deficiencies indicate a lack of thoroughness in their quality system's handling of product issues and corrective measures.

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.keypedia.com/companies/edwards-lifesciences-technology-sarl/42a7d334-7d45-4aef-8eef-d3a28ee5ded6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6