FDA Inspection 1049851 — AVEVA Drug Delivery Systems, Inc.
The FDA completed an inspection of AVEVA Drug Delivery Systems, Inc. on Apr 27, 2018 in Miramar, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 27, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |