FDA Inspection
EUGIA Pharma Specialities LimitedEUGIA Pharma Specialities Limited – FDA Inspection, Aug 28, 2019
Record Details
This FDA Inspection record concerns EUGIA Pharma Specialities Limited, with an inspection on August 28, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · a3d012ab-26cd-4cdb-9436-f0f8ba443dac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100694
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(1)Samples (various types) representative, identified properly
- 21 CFR 211.192Quality control unit review of records
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Other FDA inspections of EUGIA Pharma Specialities Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| July 26, 2023 | NAI | Drug Quality Assurance | |
| November 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 8, 2018 | Not classified | Office of Inspections and Investigations | |
| December 14, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for EUGIA Pharma Specialities Limited
- FDA Inspection 1304662 - 2026-02-27
- FDA Inspection 1234157 - 2023-07-26
- FDA Inspection 1234762 - 2022-11-25
- FDA Inspection 1057278 - 2018-06-08
- FDA Inspection 1039097 - 2017-12-14
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