UBE Analytical Laboratories, Inc. – FDA Inspection, Sep 24, 2018

Record Details

This FDA Inspection record concerns UBE Analytical Laboratories, Inc., with an inspection on September 24, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: UBE Analytical Laboratories, Inc.
Inspection Date: September 24, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Marcus F. Yambot (FDA Associated Person)

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ID · d820159e-fa1f-4ff7-bf43-db3ca085e6b9

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1067745
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.68(b)Computer control of master formula records
21 CFR 211.160(a)Deviations from laboratory control requirements
21 CFR 211.68(b)Backup file not maintained
21 CFR 211.194(a)Complete test data included in records
21 CFR 211.165(e)Test methods
21 CFR 211.160(a)Lab controls established, including changes
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

UBE Analytical Laboratories, Inc.September 24, 2018