FDA Inspection
Pharmaplast S.A.E.Pharmaplast S.A.E. – FDA Inspection, Feb 6, 2025
Record Details
This FDA Inspection record concerns Pharmaplast S.A.E., with an inspection on February 6, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · c3108f0c-4c43-438e-b05d-11df155af929
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1260910
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Pharmaplast S.A.E.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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