FDA Inspection
Luen Fook Medicine Sdn. Bhd.Luen Fook Medicine Sdn. Bhd. – FDA Inspection, May 22, 2015
Record Details
This FDA Inspection record concerns Luen Fook Medicine Sdn. Bhd., with an inspection on May 22, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Luen Fook Medicine Sdn. Bhd.
- Inspection Date
- May 22, 2015
- Product Type
- Drugs
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ID · b87b87c3-4b31-4615-954c-b8e0bcbe394e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 928839
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Luen Fook Medicine Sdn. Bhd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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