FDA Inspection
Tai Guk Pharm Co., Ltd., Buyeo branchTai Guk Pharm Co., Ltd., Buyeo branch – FDA Inspection, Oct 19, 2018
Record Details
This FDA Inspection record concerns Tai Guk Pharm Co., Ltd., Buyeo branch, with an inspection on October 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ac735d83-ab70-48e2-9ff7-9d7e02d6f99e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069204
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.184(d)Labeling: documentation of exam and review
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Tai Guk Pharm Co., Ltd., Buyeo branch
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| January 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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