FDA Inspection 626585 — AVEVA Drug Delivery Systems, Inc.
The FDA completed an inspection of AVEVA Drug Delivery Systems, Inc. on December 4, 2009 in Miramar, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 4, 2009
- Fiscal Year
- 2010
- 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 |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1541 | 21 CFR 211.125(b) | Examination of issued labels |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |