FDA Inspection 1216787 — AVEVA Drug Delivery Systems, Inc.
The FDA completed an inspection of AVEVA Drug Delivery Systems, Inc. on September 1, 2023 in Miramar, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 1, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |