FDA Inspection
Sentara Infusion ServicesSentara Infusion Services – FDA Inspection, Dec 16, 2022
Record Details
This FDA Inspection record concerns Sentara Infusion Services, with an inspection on December 16, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sentara Infusion Services
- Inspection Date
- December 16, 2022
- Product Type
- Drugs
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ID · 8c23963a-af93-4502-9951-7946cec0b8cb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1193101
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- Disinfecting and cleaning agents, ISO 5 area
- Disinfecting materials, aseptic processing area
- First pass air blockage, open unit with sterile product
- Exposure of personnel in aspectic processing
- Personnel contact outside ISO 5 area
- Cleanliness, ISO-classified areas
- Actionable microbial contamination, adjacent area
- Beta-lactam drugs, inadequate sanitation
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Other FDA inspections of Sentara Infusion Services
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 6, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 23, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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