Eurofins SF Analytical Laboratories, Inc. – FDA Inspection, Jun 6, 2013

Record Details

This FDA Inspection record concerns Eurofins SF Analytical Laboratories, Inc., with an inspection on June 6, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Eurofins SF Analytical Laboratories, Inc.
Inspection Date: June 6, 2013
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 3e7ac8d6-4dd3-4312-bfa7-994075db6b6d

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 833782
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.160(a)Deviations from laboratory control requirements
21 CFR 211.25(a)Training--operations, GMPs, written procedures
21 CFR 211.194(c)Testing and standardization of standards et. al.
21 CFR 211.165(e)Test methods
21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
21 CFR 211.160(a)Lab controls established, including changes
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs

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FDA Inspection

Eurofins SF Analytical Laboratories, Inc.June 6, 2013