FDA Inspection
Eugia Pharma Specialities LimitedEugia Pharma Specialities Limited – FDA Inspection, Apr 28, 2017
Record Details
This FDA Inspection record concerns Eugia Pharma Specialities Limited, with an inspection on April 28, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · cf884f6b-12c0-430a-889f-62bebe6a47fe
Inspection Facts
- Inspection number
- 1010785
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.63Equipment Design, Size and Location
- 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 |
| February 20, 2018 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| September 16, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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