FDA Inspection
EUGIA Pharma Specialities LimitedEUGIA Pharma Specialities Limited – FDA Inspection, May 3, 2024
Record Details
This FDA Inspection record concerns EUGIA Pharma Specialities Limited, with an inspection on May 3, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3355411d-e41b-4c80-996a-52a2f30284df
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1238749
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EUGIA Pharma Specialities Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | OAI | 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 |
| March 6, 2018 | 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 1227549 - 2022-06-24
- FDA Inspection 1155857 - 2019-01-18
- FDA Inspection 1043313 - 2018-03-06
- FDA Inspection 944865 - 2015-09-25
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