# FDA 483 - Moldex-Metric, Inc. - March 05, 2026

Source: https://www.keypedia.com/records/483/moldex-metric-inc/ae0ab39e-60ed-4345-804f-eac4d4724c54

> FDA 483 for Moldex-Metric, Inc. on March 05, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Moldex-Metric, Inc.
- Inspection Date: 2026-03-05
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Moldex-Metric, Inc. in Culver City, CA, a medical device manufacturer, identified two observations related to quality system deficiencies. The firm failed to maintain records of risk management activities for its N95 Healthcare and Surgical Mask Family of Product and did not maintain a design and development file for this medical device family.

## Related Documents

- [483 - 2022-05-20](https://www.keypedia.com/records/483/moldex-metric-inc/3149db06-9e06-40e1-8ccc-6d99d40091a6)

## Related Officers

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

Company: https://www.keypedia.com/companies/moldex-metric-inc/06a71b94-468a-453d-a92b-67f72c033cf4

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b