# FDA 483 - Novatek, LLC - February 18, 2022

Source: https://www.keypedia.com/records/483/novatek-llc/2c4f9f01-b21d-4bea-8b5e-e77a4cd63e1f

> FDA 483 for Novatek, LLC on February 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novatek, LLC
- Inspection Date: 2022-02-18
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Novatek, LLC in Camarillo, CA, a medical device manufacturer, was inspected by the FDA on February 15 and 18, 2022. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the lack of established procedures for corrective and preventive actions and device history records. These findings indicate a fundamental breakdown in critical quality management processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/novatek-llc/968ea6c5-2cf6-4edc-8789-aab90b8a8bdc

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