FDA Inspection 1154338 — InfuScience, Inc. dba Bioscrip Infusion Services
The FDA completed an inspection of InfuScience, Inc. dba Bioscrip Infusion Services on October 8, 2021 in Chantilly, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 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 |