FDA Inspection
PharmaGend Global Medical Services Pte. Ltd.PharmaGend Global Medical Services Pte. Ltd. – FDA Inspection, Feb 1, 2019
Record Details
This FDA Inspection record concerns PharmaGend Global Medical Services Pte. Ltd., with an inspection on February 1, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- February 1, 2019
- Product Type
- Human Drugs
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ID · ac4fdb96-55e6-4185-8050-c3a484ba1a6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078346
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of PharmaGend Global Medical Services Pte. Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PharmaGend Global Medical Services Pte. Ltd.
- FDA Inspection 1180084 - 2022-08-08
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