# FDA 483 - Advanced Botanical Consulting & Testing, LLC - November 13, 2018

Source: https://www.globalkeysolutions.net/records/483/advanced-botanical-consulting-testing-llc/65fb4dd3-3f59-42b2-8638-ad4c00209fc6

> FDA 483 for Advanced Botanical Consulting & Testing, LLC on November 13, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Botanical Consulting & Testing, LLC
- Inspection Date: 2018-11-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Advanced Botanical Consulting & Testing Inc dba ABC Testing, a contract testing laboratory in Tustin, CA, was cited for significant deficiencies in its laboratory operations. Observations included inadequate method suitability verification, incomplete laboratory records, insufficient computer system controls, and a lack of change control for laboratory mechanisms. Additionally, the firm failed to perform routine equipment calibration and validation according to written programs.

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## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.globalkeysolutions.net/companies/advanced-botanical-consulting-testing-llc/39b72f9e-c753-4ae3-baff-2a7194ed173c

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