FDA Inspection 1043313 — EUGIA Pharma Specialities Limited
The FDA completed an inspection of EUGIA Pharma Specialities Limited on Mar 6, 2018 in Riico Industrial Area. 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
- Mar 6, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Riico Industrial Area (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |