FDA Inspection
AVEVA Drug Delivery Systems, Inc.AVEVA Drug Delivery Systems, Inc. – FDA Inspection, Sep 28, 2011
Record Details
This FDA Inspection record concerns AVEVA Drug Delivery Systems, Inc., with an inspection on September 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 28, 2011
- Product Type
- Drugs
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ID · 089f45c9-aa66-4543-b3e7-7f1aeb6f5892
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 742495
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.80(a)Written Procedures Not Followed
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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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