Skylake Co., Ltd. – FDA Inspection, Jul 17, 2018

Record Details

This FDA Inspection record concerns Skylake Co., Ltd., with an inspection on July 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Skylake Co., Ltd.
Inspection Date: July 17, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Nancy M. Espinal (FDA Associated Person)

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ID · 81012668-3c94-4b9f-ad18-7765d0aa0c8d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1062645
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.105(a)Identification of containers, lines, equipment
21 CFR 211.122(a)Written procedures describing in detail
21 CFR 211.80(a)Written Procedures Not Followed

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FDA Inspection

Skylake Co., Ltd.July 17, 2018