FDA Inspection
Kolmar Korea Co., Ltd. - Gwanjeong FactoryKolmar Korea Co., Ltd. - Gwanjeong Factory – FDA Inspection, Feb 16, 2024
Record Details
This FDA Inspection record concerns Kolmar Korea Co., Ltd. - Gwanjeong Factory, with an inspection on February 16, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · edc9193f-46a0-4074-938e-5d7c77446b1c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230224
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.130(c)Lot or control number assigned
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Other FDA inspections of Kolmar Korea Co., Ltd. - Gwanjeong Factory
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 7, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kolmar Korea Co., Ltd. - Gwanjeong Factory
- FDA Inspection 1173870 - 2022-07-07
- FDA Inspection 1031995 - 2017-09-15
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