1028352
Polaroisin International Co., Ltd. — FEI 3008004582
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Taipei City (Taiwan)
Citations
| ID | CFR | Description |
|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |