FDA Inspection 869949 — Vertrauen Chemie Solutions Inc
The FDA completed an inspection of Vertrauen Chemie Solutions Inc on March 7, 2014 in Mckinney, TX. 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
- March 7, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mckinney, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |