FDA Inspection
Eugia Pharma Specialities LimitedEugia Pharma Specialities Limited – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Eugia Pharma Specialities Limited, with an inspection on December 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Atul Agrawal (Issuing Officer)
- Jose A. Cruz Gonzalez
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ID · 8a7d51e6-f2bc-408c-931c-6c2f2a26379d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074573
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
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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 |
| 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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