FDA Inspection
Eugia Pharma Specialities LimitedEugia Pharma Specialities Limited – FDA Inspection, Feb 6, 2026
Record Details
This FDA Inspection record concerns Eugia Pharma Specialities Limited, with an inspection on February 6, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · dad2a99c-72eb-441c-b664-de937e749c6e
Inspection Facts
- Inspection number
- 1301166
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 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 211.165(a)Testing and release for distribution
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Eugia Pharma Specialities Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2024 | OAI | Center for Drug Evaluation and Research | 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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