FDA Inspection
Luen Wah (HK) Medicine LtdLuen Wah (HK) Medicine Ltd – FDA Inspection, Sep 28, 2017
Record Details
This FDA Inspection record concerns Luen Wah (HK) Medicine Ltd, with an inspection on September 28, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8fb70e1a-5578-4fd5-a36d-94f668b0fa08
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1028354
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192No written record of investigation
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