FDA Inspection
Eugia Pharma Specialities LimitedEugia Pharma Specialities Limited – FDA Inspection, Feb 2, 2024
Record Details
This FDA Inspection record concerns Eugia Pharma Specialities Limited, with an inspection on February 2, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 85cbcceb-815e-487e-9426-4c272f86d63a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1228546
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Eugia Pharma Specialities Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| December 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2018 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| April 28, 2017 | Not classified | Office of Inspections and Investigations | Generic Drug Evaluation |
| September 16, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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