FDA Inspection
Luen Fook Medicine Sdn. Bhd.Luen Fook Medicine Sdn. Bhd. – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Luen Fook Medicine Sdn. Bhd., with an inspection on December 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4f59d3b8-be47-4207-9ed4-1335c733527d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1074955
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
10- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Luen Fook Medicine Sdn. Bhd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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