# FDA 483 - Advanced Botanical Consulting & Testing, LLC - March 15, 2021

Source: https://www.keypedia.com/records/483/advanced-botanical-consulting-testing-llc/58f2180a-839b-4e5d-a1b8-b5976bb7a894

> FDA 483 for Advanced Botanical Consulting & Testing, LLC on March 15, 2021. 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: 2021-03-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Advanced Botanical Consulting & Testing, LLC dba ABC Testing in Tustin, CA, was inspected and cited for significant deficiencies in its laboratory control systems. The inspection revealed systemic issues including unverified testing methods, disabled computer system audit trails, lack of change control for laboratory procedures and equipment, and inadequate personnel and equipment qualification/calibration. These findings indicate a severe lack of quality oversight and control in their contract testing operations.

## Related Documents

- [483 - 2012-03-16](https://www.keypedia.com/records/483/advanced-botanical-consulting-testing-llc/10939280-8cac-44ca-9c61-38acafdea32d)
- [483 - 2012-03-16](https://www.keypedia.com/records/483/advanced-botanical-consulting-testing-llc/9b5f0b3d-3e6e-4e72-b2c4-12acc4d802d0)
- [483 - 2018-11-13](https://www.keypedia.com/records/483/advanced-botanical-consulting-testing-llc/36ebd513-ca00-416d-9ae0-263a58b12447)
- [483 - 2018-11-13](https://www.keypedia.com/records/483/advanced-botanical-consulting-testing-llc/65fb4dd3-3f59-42b2-8638-ad4c00209fc6)

## Related Officers

- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

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

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