Caregen Co., Ltd. – FDA Inspection, Jun 29, 2018

Record Details

This FDA Inspection record concerns Caregen Co., Ltd., with an inspection on June 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Caregen Co., Ltd.
Inspection Date: June 29, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Nayan J. Patel (FDA Associated Person)

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ID · cee99137-a7a3-4638-a3a2-e7a2e7d4f239

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1058289
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.68(b)Backup data not assured as exact and complete
21 CFR 211.84(d)(6)Microbiological Contamination Exam
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

Caregen Co., Ltd.June 29, 2018