# FDA 483 - Expert Chemical Analysis, Inc. - October 07, 2021

Source: https://www.globalkeysolutions.net/records/483/expert-chemical-analysis-inc/a9126903-3ae6-4ff6-b3df-a6bb6e74ea11

> FDA 483 for Expert Chemical Analysis, Inc. on October 07, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Expert Chemical Analysis, Inc.
- Inspection Date: 2021-10-07
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Expert Chemical Analysis, Inc. in San Diego, CA, a laboratory, revealed significant deficiencies across its quality system and laboratory operations. Observations included the absence of a quality control unit, inadequate investigations into out-of-specification results, and a failure to validate test methods. The firm also lacked proper documentation for equipment calibration and sufficient controls over analytical computer systems.

## Related Officers

- [https://www.fda.gov/media/120628/download](https://www.globalkeysolutions.net/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

Company: https://www.globalkeysolutions.net/companies/expert-chemical-analysis-inc/c56ac209-2bc5-46e2-9839-81c350a3ef03

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