FDA Inspection
Novugen Oncology Sdn. Bhd.Novugen Oncology Sdn. Bhd. – FDA Inspection, Jul 21, 2023
Record Details
This FDA Inspection record concerns Novugen Oncology Sdn. Bhd., with an inspection on July 21, 2023, issued by the Office of Inspections and Investigations.
- Company
- Novugen Oncology Sdn. Bhd.
- Inspection Date
- July 21, 2023
View Company Profile
ID · 563695a7-e145-4f34-8dec-a6d855026b89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210629
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.68(b)input/output verification
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Other FDA inspections of Novugen Oncology Sdn. Bhd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2026 | Not classified | Office of Inspections and Investigations |
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