FDA Inspection
JO Cosmetics Co., Ltd.JO Cosmetics Co., Ltd. – FDA Inspection, Jul 14, 2017
Record Details
This FDA Inspection record concerns JO Cosmetics Co., Ltd., with an inspection on July 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5b5fcd70-beb1-48c8-8558-62798293d229
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017865
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.101(b)(4)Subdivided component/container/finished drug
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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