483
Advanced Botanical Consulting & Testing, LLCAdvanced Botanical Consulting & Testing, LLC – FDA 483, Nov 13, 2018
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.
- Inspection date
- November 13, 2018
- Product type
- drugs
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ID · 65fb4dd3-3f59-42b2-8638-ad4c00209fc6
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