FDA Inspection
Pharmaplast S.A.E.Pharmaplast S.A.E. – FDA Inspection, Nov 10, 2022
Record Details
This FDA Inspection record concerns Pharmaplast S.A.E., with an inspection on November 10, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pharmaplast S.A.E.
- Inspection Date
- November 10, 2022
- Product Type
- Drugs
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ID · d8a31311-5b8f-4f3f-8de7-e2bc2061824b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1190349
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.48(a)Potable water not under positive pressure
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Pharmaplast S.A.E.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2025 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
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