# FDA 483 - BELLFX - March 31, 2022

Source: https://www.keypedia.com/records/483/bellfx/ce4e7c62-125a-48a3-aafb-b060b78b2569

> FDA 483 for BELLFX on March 31, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BELLFX
- Inspection Date: 2022-03-31
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: During an inspection, BELLFX, a medical device manufacturer in San Fernando, CA, was cited for a single observation related to inadequate documentation of process validation activities. The firm failed to document the installation, operational, and performance qualification activities and results for CNC machines used in manufacturing Class II medical devices.

## Related Officers

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

Company: https://www.keypedia.com/companies/bellfx/b1cd44d3-c3ed-47bb-941c-31e3aa297f96

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