FDA Inspection 946109 — Advanced Infusion Solutions Acquisition, LLC
The FDA completed an inspection of Advanced Infusion Solutions Acquisition, LLC on Oct 27, 2015 in Ridgeland, MS. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 27, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ridgeland, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |