# FDA 483 - Clinical Resolution Laboratory Inc. - January 16, 2025

Source: https://www.keypedia.com/records/483/clinical-resolution-laboratory-inc/219f3d62-c8a1-49cc-a2a4-2f2258a83a08

> FDA 483 for Clinical Resolution Laboratory Inc. on January 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clinical Resolution Laboratory Inc.
- Inspection Date: 2025-01-16
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Clinical Resolution Laboratory Inc. in Brea, CA, a drug manufacturer, was cited with five observations during an FDA inspection from January 7-16, 2025. The inspection revealed significant deficiencies primarily related to quality control, including inadequate investigations into out-of-specification results, insufficient component testing, and issues with water system design. Additionally, the firm's batch production and control records were found to be deficient and inconsistent with master records and process validation.

## Related Documents

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- [483 - 2023-09-29](https://www.keypedia.com/records/483/clinical-resolution-laboratory-inc/e7e13a97-7fd6-45c9-83b7-5a09b128666c)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Thuy Tram L. Nguyen](https://www.keypedia.com/people/thuy-tram-l-nguyen/b58f2445-728e-4f79-b7eb-4dfb7e982e25)

Company: https://www.keypedia.com/companies/clinical-resolution-laboratory-inc/c7dca0ab-3aac-4500-9aa4-7ba4320b58cf

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