# FDA 483 - Micro Therapeutics,  Inc. - September 17, 2021

Source: https://www.keypedia.com/records/483/micro-therapeutics-inc/1763be80-496e-450b-9857-5512df5b0b1b

> FDA 483 for Micro Therapeutics,  Inc. on September 17, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Therapeutics,  Inc.
- Inspection Date: 2021-09-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Micro Therapeutics, Inc. in Irvine, California, a medical device manufacturer, was inspected and received a Form FDA 483 with six observations indicating significant quality system deficiencies. The inspection revealed failures in controlling non-conforming product, design change procedures, supplier management, product control, corrective and preventive actions, and employee training, which collectively led to multiple Class I product recalls. The findings suggest systemic issues in maintaining product quality and regulatory compliance.

## Related Officers

- [Sonya L. Karsik](https://www.keypedia.com/people/sonya-l-karsik/c24603b9-5ca0-46f5-861a-b367155b0def)

Company: https://www.keypedia.com/companies/micro-therapeutics-inc/fcf4c33c-c4de-4186-a6d1-eaab749d43cc

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