Advanced Botanical Consulting & Testing, LLCNovember 13, 2018

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Advanced Botanical Consulting & Testing, LLC

Record Details

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.

Company: Advanced Botanical Consulting & Testing, LLC
Inspection Date: November 13, 2018
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
Person: Rumany C. Penn (Compliance Officer)

Open in Dashboard

ID · 65fb4dd3-3f59-42b2-8638-ad4c00209fc6