Company
MalaysiaPoon Goor Soe Manufacture Sdn Bhd, Melaka Tengah, Malaysia – FDA Inspections
Inspection records and compliance data for Poon Goor Soe Manufacture Sdn Bhd in Melaka Tengah. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected July 26, 2019.
Company Profile
This profile covers Poon Goor Soe Manufacture Sdn Bhd based in Melaka Tengah, Malaysia.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected July 26, 2019.
Most cited issue areas
- Complete test data included in records1 inspection
- Control procedures to monitor and validate performance1 inspection
- Lack of written stability program1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1097510 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Poon Goor Soe Manufacture Sdn Bhd
FEI Number
3006339577
Address
No. 5 Jalan Iks M4 Taman IKS Merdeka Batu Berendam, Melaka Tengah, Malaysia
Country
Malaysia
ID: 3d141577-c52c-4116-a950-2c7eb157beca