FDA Inspection
AVEVA Drug Delivery Systems, Inc.AVEVA Drug Delivery Systems, Inc. – FDA Inspection, Dec 4, 2009
Record Details
This FDA Inspection record concerns AVEVA Drug Delivery Systems, Inc., with an inspection on December 4, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 4, 2009
- Product Type
- Drugs
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ID · 954708a7-d9cb-4b82-bd16-06e44b3b4ecf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 626585
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.130(e)Packaging line inspection after use
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.125(b)Examination of issued labels
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
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Other FDA inspections of AVEVA Drug Delivery Systems, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2026 | Not classified | Florida District Office | Drug Quality Assurance |
| September 1, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2019 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| April 27, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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