FDA Inspection 961288 — SWISSCAPS Romania SRL
The FDA completed an inspection of SWISSCAPS Romania SRL on February 19, 2016 in Cornu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cornu (Romania)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2404 | 21 CFR 211.194(a)(6) | Comparison of Test Results to Specifications |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |