FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Jan 11, 2013
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on January 11, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fresenius Kabi USA, LLC
- Inspection Date
- January 11, 2013
- Product Type
- Drugs
View Company Profile
ID · 41cd610e-7371-4adb-b525-c6651aca82ab
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 815426
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.180(c)Photocopying of records not allowed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/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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