FDA Inspection
Advanced Infusion Solutions Acquisition, LLCAdvanced Infusion Solutions Acquisition, LLC – FDA Inspection, Oct 27, 2015
Record Details
This FDA Inspection record concerns Advanced Infusion Solutions Acquisition, LLC, with an inspection on October 27, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 27, 2015
- Product Type
- Drugs
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ID · 3c28bc23-e7e9-4850-886d-d43c7117118a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 946109
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
6- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
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Other FDA inspections of Advanced Infusion Solutions Acquisition, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Advanced Infusion Solutions Acquisition, LLC
- FDA Inspection 1035766 - 2017-11-15
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