FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Jan 13, 2010
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on January 13, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fresenius Kabi USA, LLC
- Inspection Date
- January 13, 2010
- Product Type
- Drugs
View Company Profile
ID · da7a3c6f-4d14-43b9-a2a7-ac0534b17829
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 640082
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Fresenius Kabi USA, LLC
15| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| 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 |
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