FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, May 14, 2026
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on May 14, 2026, issued by the New York District Office, covering human drugs.
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ID · 7806c7ac-e4b7-48bb-acf4-27fe0402e176
Inspection Facts
- Inspection number
- 1317954
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
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Other FDA inspections of Fresenius Kabi USA, LLC
15| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2018 | Not classified | New York District Office | |
| March 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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