FDA Inspection
Wong Lap Kwong Medicine Company LimitedWong Lap Kwong Medicine Company Limited – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Wong Lap Kwong Medicine Company Limited, with an inspection on September 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · deaa7a89-3367-4e57-bb18-30d82bc2636d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1026084
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
25- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.160(b)(2)Acceptance of in-process materials
- 21 CFR 211.84(d)(3)Container/Closure Written Test Procedure
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.110(c)In-process materials characteristics testing
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