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1136796

Advanced Botanical Consulting & Testing, LLC — FEI 3003693795

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 15, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tustin, CA (United States)

Facility

Other inspections at this facility

  • 1072344 (OAI Tue Nov 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
113621 CFR 211.25(c)Inadequate number of personnel
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
180921 CFR 211.160(a)Following/documenting laboratory controls
181021 CFR 211.160(a)Lab controls established, including changes
203321 CFR 211.194(c)Testing and standardization of standards et. al.
239921 CFR 211.194(a)(2)Laboratory Test Method Verification
360621 CFR 211.160(b)(1)Retesting
440621 CFR 211.194(a)(2)Suitability of testing methods verified