# FDA 483 - Adamson Analytical Laboratories, Inc. - March 23, 2021

Source: https://www.globalkeysolutions.net/records/483/adamson-analytical-laboratories-inc/3525c88f-b6b6-41a8-a13b-a929ce6e9045

> FDA 483 for Adamson Analytical Laboratories, Inc. on March 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Adamson Analytical Laboratories, Inc.
- Inspection Date: 2021-03-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Adamson Analytical Laboratories, Inc. in Corona, CA, was cited for significant deficiencies in its analytical laboratory operations. The inspection revealed widespread issues with method validation, computer system controls, quality unit oversight of records and investigations, and change control procedures. These findings indicate a severe lack of control over critical laboratory processes impacting the quality and integrity of drug product testing.

## Related Documents

- [483 - 2017-02-10](https://www.globalkeysolutions.net/records/483/adamson-analytical-laboratories-inc/ae7549dd-e5aa-40a9-a4d7-1491da7d8288)
- [WARNING_LETTER - 2021-03-23](https://www.globalkeysolutions.net/records/warning_letter/adamson-analytical-laboratories-inc/d9a8da45-c585-45ee-be56-26366467e36b)
- [483 - 2022-10-04](https://www.globalkeysolutions.net/records/483/adamson-analytical-laboratories-inc/e920d295-d90c-4437-815f-de43afe3142d)
- [483 - 2024-09-12](https://www.globalkeysolutions.net/records/483/adamson-analytical-laboratories-inc/915569d2-ff3b-43de-9194-f0e1d8762b08)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Pharmaceutical investigator](https://www.globalkeysolutions.net/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.globalkeysolutions.net/companies/adamson-analytical-laboratories-inc/d2272f1b-3ee8-41d3-9c22-8dbea76ca9a1

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