FDA Inspection
Amorepacific CorporationAmorepacific Corporation – FDA Inspection, Mar 16, 2024
Record Details
This FDA Inspection record concerns Amorepacific Corporation, with an inspection on March 16, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fe837471-5954-413b-8256-a73400e39ae3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233111
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Written record of investigation incomplete
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