FDA Inspection 1084645 — Swiss Pharmaceutical Company Ltd
The FDA completed an inspection of Swiss Pharmaceutical Company Ltd on Mar 22, 2019 in Tai Nan Shi. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 22, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tai Nan Shi (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1270 | 21 CFR 211.68(b) | input/output verification |