Barox Co., Ltd. – FDA Inspection, May 18, 2018

Record Details

This FDA Inspection record concerns Barox Co., Ltd., with an inspection on May 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Barox Co., Ltd.
Inspection Date: May 18, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Sangeeta M. Khurana (FDA Associated Person)

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ID · 5ae03b38-dbe9-4a98-a76e-1cd247a49a26

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1052335
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.25(a)Training--operations, GMPs, written procedures
21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.100(a)Approval and review of procedures

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FDA Inspection

Barox Co., Ltd.May 18, 2018