# FDA 483 - PRIME MATTER LABS WEST LLC - August 25, 2022

Source: https://www.keypedia.com/records/483/prime-matter-labs-west-llc/2e2bb77b-f5d6-4895-a3ff-37614c5b7925

> FDA 483 for PRIME MATTER LABS WEST LLC on August 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PRIME MATTER LABS WEST LLC
- Inspection Date: 2022-08-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: PRIME MATTER LABS WEST LLC in Torrance, CA, a manufacturer, was cited for three significant issues during an FDA inspection. These included an inadequate investigation into microbial contamination of an SPF 50 product, a failure to calibrate a critical thermometer used in drug batch production, and a deficiency in validating supplier certificates of analysis for active pharmaceutical ingredients. The findings indicate a lack of thoroughness in quality control and supplier management practices.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)

Company: https://www.keypedia.com/companies/prime-matter-labs-west-llc/4df59898-79c3-47d4-afd9-8ee048c0d349

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