FDA Inspection
Pharmathen International S.A.Pharmathen International S.A. – FDA Inspection, Nov 21, 2025
Record Details
This FDA Inspection record concerns Pharmathen International S.A., with an inspection on November 21, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · e0900848-9b03-4fb2-96e7-5bf0a83e2211
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1292960
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
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Other FDA inspections of Pharmathen International S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| October 26, 2017 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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