# FDA 483 - Prescient Surgical, Inc. - July 19, 2019

Source: https://www.keypedia.com/records/483/prescient-surgical-inc/f7304a6c-7791-4726-90b4-8ff52c980011

> FDA 483 for Prescient Surgical, Inc. on July 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prescient Surgical, Inc.
- Inspection Date: 2019-07-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Prescient Surgical, Inc. in San Carlos, CA, a medical device manufacturer, was cited with three observations during an FDA inspection. The inspection revealed deficiencies in process validation, design control procedures, and documentation of acceptance activities, indicating a need for improved quality system controls.

## Related Officers

- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/prescient-surgical-inc/30dd6eaf-b213-4f16-a778-423a572ec99d

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6