FDA Inspection 742495 — AVEVA Drug Delivery Systems, Inc.
The FDA completed an inspection of AVEVA Drug Delivery Systems, Inc. on September 28, 2011 in Miramar, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 28, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |