FDA Inspection
Vertrauen Chemie Solutions IncVertrauen Chemie Solutions Inc – FDA Inspection, Jan 4, 2012
Record Details
This FDA Inspection record concerns Vertrauen Chemie Solutions Inc, with an inspection on January 4, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 4, 2012
- Product Type
- Drugs
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ID · 7e7c98ae-55e6-4597-bc03-2ba2fb560e58
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 759387
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.165(c)Sampling and testing plans not described
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Vertrauen Chemie Solutions Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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