FDA Inspection 1050666 — Eugia SEZ Private Limited
The FDA completed an inspection of Eugia SEZ Private Limited on May 4, 2018 in Mahabubnagar District. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mahabubnagar District (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |