FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Jun 13, 2023
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on June 13, 2023, issued by the Center for Drug Evaluation and Research.
- Company
- Fresenius Kabi USA, LLC
- Inspection Date
- June 13, 2023
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ID · 3f7473e4-3934-4091-8c49-a061d9abf405
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1208507
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188(b)(12)Documentation of Batch Investigations
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.113(b)Validation lacking for sterile drug products
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Other FDA inspections of Fresenius Kabi USA, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | Atlanta District Office | |
| February 8, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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