Laboratorios Le Roy, S.A. de C.V. – FDA Inspection, Jul 20, 2018

Record Details

This FDA Inspection record concerns Laboratorios Le Roy, S.A. de C.V., with an inspection on July 20, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Laboratorios Le Roy, S.A. de C.V.
Inspection Date: July 20, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Michael A. Charles (FDA Associated Person)

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ID · 1b48897b-406a-4f18-9c51-9977b74b5d73

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1059751
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.84(d)(1)Component identity verification
21 CFR 211.165(b)Microbiological testing
21 CFR 211.67(b)(2)Cleaning SOPs/schedules
21 CFR 211.166(a)Lack of written stability program

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FDA Inspection

Laboratorios Le Roy, S.A. de C.V.July 20, 2018