FDA Inspection
InfuScience, Inc. dba Bioscrip Infusion ServicesInfuScience, Inc. dba Bioscrip Infusion Services – FDA Inspection, Jul 30, 2019
Record Details
This FDA Inspection record concerns InfuScience, Inc. dba Bioscrip Infusion Services, with an inspection on July 30, 2019, issued by the Baltimore District Office, covering human drugs.
- Inspection Date
- July 30, 2019
- Product Type
- Human Drugs
- Person
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ID · 9f484cf3-1843-4f6b-9780-3baf3b92b3c6
Inspection Facts
- Inspection number
- 1099044
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- FDCA 501(a)(2)(A)Beta-lactam drugs, inadequate sanitation
- FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
- FDCA 501(a)(2)(A)Disinfectant contact time
- FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area
- FDCA 501(a)(2)(A)First pass air blockage, open unit with sterile product
- FDCA 501(a)(2)(A)Personnel habits, contamination
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Other FDA inspections of InfuScience, Inc. dba Bioscrip Infusion Services
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 8, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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