FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Jun 24, 2016
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on June 24, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fresenius Kabi USA, LLC
- Inspection Date
- June 24, 2016
- Product Type
- Drugs
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ID · e7df94d1-c707-4569-b8db-0bd30fcf97bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988705
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.188(b)(12)Documentation of Batch Investigations
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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 |
| June 13, 2023 | OAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| 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 |
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