FDA Inspection
Pharmathen International S.A.Pharmathen International S.A. – FDA Inspection, Oct 26, 2017
Record Details
This FDA Inspection record concerns Pharmathen International S.A., with an inspection on October 26, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · c123608f-8fad-4849-8957-2a0934dc94ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030182
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)(3)Sampling/testing of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Pharmathen International S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
| December 9, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2019 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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