# FDA 483 - Moldex-Metric, Inc. - May 20, 2022

Source: https://www.keypedia.com/records/483/moldex-metric-inc/3149db06-9e06-40e1-8ccc-6d99d40091a6

> FDA 483 for Moldex-Metric, Inc. on May 20, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Moldex-Metric, Inc.
- Inspection Date: 2022-05-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Moldex-Metric, Inc., a medical device manufacturer in Culver City, CA, was inspected by the FDA. The inspection revealed a significant issue with the lack of documentation for process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for their automated mask molding machines. This indicates a failure to properly record critical manufacturing process parameters and results for 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/moldex-metric-inc/06a71b94-468a-453d-a92b-67f72c033cf4

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