FDA Inspection
Pharmathen International S.A.Pharmathen International S.A. – FDA Inspection, Apr 19, 2019
Record Details
This FDA Inspection record concerns Pharmathen International S.A., with an inspection on April 19, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 4e1a57a2-1c7e-4959-b5cd-8eed428d08a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087410
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)Computer control of master formula records
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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 |
| October 26, 2017 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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