MEIYUME (UK) Ltd. – FDA Inspection, Sep 19, 2019

Record Details

This FDA Inspection record concerns MEIYUME (UK) Ltd., with an inspection on September 19, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: MEIYUME (UK) Ltd.
Inspection Date: September 19, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Jose O. Hernandez (Company Rep)

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ID · e1350f6e-7f5e-4eeb-8268-7ea3d7f21907

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1102230
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.142(b)Storage under appropriate conditions
21 CFR 211.25(a)Training , Education , Experience overall
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.22(c)Approve or reject procedures or specs
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.182Written records kept in individual logs
21 CFR 211.110(b)In-process specification, invalid

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FDA Inspection

MEIYUME (UK) Ltd.September 19, 2019