FDA Inspection
Eugia SEZ Private LimitedEugia SEZ Private Limited – FDA Inspection, Feb 29, 2024
Record Details
This FDA Inspection record concerns Eugia SEZ Private Limited, with an inspection on February 29, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 91768552-be63-4255-86b0-d546cdfd6d0f
Inspection Facts
- Inspection number
- 1231363
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Backup file not maintained
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Other FDA inspections of Eugia SEZ Private Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2016 | Not classified | Office of Inspections and Investigations |
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