Company
MalaysiaNovugen Oncology Sdn. Bhd., Bandar Baru Enstek, Malaysia – FDA Inspections
Inspection records and compliance data for Novugen Oncology Sdn. Bhd. in Bandar Baru Enstek. 2 FDA inspections on record, 2 Form 483s, last inspected August 07, 2026.
Company Profile
This profile covers Novugen Oncology Sdn. Bhd. based in Bandar Baru Enstek, Malaysia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected July 21, 2023. Last inspected August 7, 2026.
Most cited issue areas
- Control procedures to monitor and validate performance1 inspection
- Defined areas of adequate size for operations1 inspection
- input/output verification1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2026 | Not classified | Human Drugs | 1332766 |
| July 21, 2023 | VAI | Human Drugs | 1210629 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Novugen Oncology Sdn. Bhd.
FEI Number
3022275118
Address
No 47 Jalan Lengkuk Teknologi 2, Taman Teknologi Enstek Fasa 1 Techpark@Enstek, Bandar Baru Enstek, Malaysia
Country
Malaysia
ID: 7e1b6b37-6dc6-4ab8-9389-160d85c8111f