FDA Inspection
EUGIA Pharma Specialities LimitedEUGIA Pharma Specialities Limited – FDA Inspection, Mar 6, 2018
Record Details
This FDA Inspection record concerns EUGIA Pharma Specialities Limited, with an inspection on March 6, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6984cbd9-95ca-4846-8461-186168759097
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043313
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of EUGIA Pharma Specialities Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | OAI | Drug Quality Assurance | |
| May 3, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for EUGIA Pharma Specialities Limited
- FDA Inspection 1297436 - 2025-11-14
- FDA Inspection 1238749 - 2024-05-03
- FDA Inspection 1227549 - 2022-06-24
- FDA Inspection 1155857 - 2019-01-18
- FDA Inspection 944865 - 2015-09-25
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