FDA Inspection
Kumho Dental Pharm Co., Ltd.Kumho Dental Pharm Co., Ltd. – FDA Inspection, Sep 13, 2018
Record Details
This FDA Inspection record concerns Kumho Dental Pharm Co., Ltd., with an inspection on September 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7ecfc1f3-d27f-4d9a-8e5b-10c017ab010f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066558
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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