Company
MalaysiaLuen Fook Medicine Sdn. Bhd., Johor Bahru, Malaysia – FDA Inspections
Inspection records and compliance data for Luen Fook Medicine Sdn. Bhd. in Johor Bahru. 2 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected December 14, 2018.
Company Profile
This profile covers Luen Fook Medicine Sdn. Bhd. based in Johor Bahru, Malaysia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected May 22, 2015. Last inspected December 14, 2018.
Most cited issue areas
- Annual visual exams of drug products2 inspections
- Control procedures to monitor and validate performance2 inspections
- Lack of quality control unit2 inspections
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2018 | OAI | Human Drugs · Drug Quality Assurance | 1074955 |
| May 22, 2015 | VAI | Human Drugs · Drug Quality Assurance | 928839 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Luen Fook Medicine Sdn. Bhd.
FEI Number
3001321832
Address
Taman Periindustrian Sri Plentong, No 6 Jalan Sri Plentong 5, Johor Bahru, Malaysia
Country
Malaysia
ID: 55069eb8-f000-427a-9361-3c0998df891d