# FDA 483 - POM Medical LLC - March 08, 2022

Source: https://www.globalkeysolutions.net/records/483/pom-medical-llc/8848f21f-945b-40fc-aff1-39ca3f7c4d2c

> FDA 483 for POM Medical LLC on March 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: POM Medical LLC
- Inspection Date: 2022-03-08
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: POM Medical, LLC, a medical device manufacturer in Moorpark, CA, was inspected and cited for inadequate procedures to control non-conforming products. The inspection revealed failures in documenting material review board activities, completing non-conforming product forms, and documenting rework activities. These issues indicate deficiencies in the firm's quality system for managing products that do not meet specified requirements.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/pom-medical-llc/199cca55-8416-4e5f-85ed-b19ba4d8c39f

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