FDA Inspection
Eugia Pharma Specialities LimitedEugia Pharma Specialities Limited – FDA Inspection, Feb 20, 2018
Record Details
This FDA Inspection record concerns Eugia Pharma Specialities Limited, with an inspection on February 20, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a27b351f-f62f-41cb-b50f-40902d82d76e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041554
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.165(d)Acceptance/Rejection Levels
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.68(b)Computer control of master formula records
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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 |
| 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 |
| 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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