FDA Inspection
New Vistas IncorporatedNew Vistas Incorporated – FDA Inspection, Feb 28, 2011
Record Details
This FDA Inspection record concerns New Vistas Incorporated, with an inspection on February 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- New Vistas Incorporated
- Inspection Date
- February 28, 2011
- Product Type
- Drugs
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ID · ca09f420-e649-40fa-9ca1-9bbc6c8784f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 711617
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
23- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(d)(6)Objectionable microbiological contamination
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)(2)In process materials - conformance to written specs
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
Showing 10 of 23 citations.
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Other FDA inspections of New Vistas Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 25, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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