FDA Inspection
HLSCIENCE CO.,LTDHLSCIENCE CO.,LTD – FDA Inspection, Nov 15, 2024
Record Details
This FDA Inspection record concerns HLSCIENCE CO.,LTD, with an inspection on November 15, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 3ca6169f-b499-463d-b982-5fa2678b6d41
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1254188
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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