FDA Inspection 1154338 — InfuScience, Inc.
The FDA completed an inspection of InfuScience, Inc. on Oct 8, 2021 in Chantilly, VA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 8, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chantilly, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18949 | FDCA 501(a)(2)(A) | First pass air blockage, open unit with sterile product |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |