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483
•Advanced Botanical Consulting & Testing, LLC•March 15, 2021

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

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Record Details

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.

Company
Advanced Botanical Consulting & Testing, LLC
Inspection Date
March 15, 2021
Product Type
Drugs
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Truong X. Nguyen (Investigator)
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ID · 58f2180a-839b-4e5d-a1b8-b5976bb7a894

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