# FDA 483 - Clinical Resolution Laboratory Inc. - April 27, 2021

Source: https://www.globalkeysolutions.net/records/483/clinical-resolution-laboratory-inc/d0019bb4-6172-40bb-84f9-b8ce813a2a1f

> FDA 483 for Clinical Resolution Laboratory Inc. on April 27, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clinical Resolution Laboratory Inc.
- Inspection Date: 2021-04-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Clinical Resolution Laboratory Inc. in Brea, CA, revealed severe and systemic deficiencies in their manufacturing of OTC drug products. The firm lacks an adequate Quality Control Unit, has untrained personnel, and fails to maintain proper complaint procedures, production controls, batch records, and equipment maintenance. These issues, including repeat observations, indicate a fundamental lack of adherence to Current Good Manufacturing Practices.

## Related Documents

- [WARNING_LETTER - 2021-04-27](https://www.globalkeysolutions.net/records/warning_letter/clinical-resolution-laboratory-inc/b89fc920-3fc4-4b9b-87ea-c91aae3476d7)
- [483 - 2023-09-29](https://www.globalkeysolutions.net/records/483/clinical-resolution-laboratory-inc/e7e13a97-7fd6-45c9-83b7-5a09b128666c)
- [483 - 2025-01-16](https://www.globalkeysolutions.net/records/483/clinical-resolution-laboratory-inc/219f3d62-c8a1-49cc-a2a4-2f2258a83a08)

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Claudia M. Perez-Kasmarski](https://www.globalkeysolutions.net/people/claudia-m-perez-kasmarski/ee989ba2-eb7a-47ae-8be5-7a28f748343b)

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

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