Form FDA 483 · Issued 2026-05-14
Fresenius Kabi USA, LLC — FDA Form 483 Analysis
FEI: 3001833549 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Fresenius Kabi USA, LLC (FEI 3001833549) on 2026-05-14 following an inspection of its sterile drug manufacturer operations in New York. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.192
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
No written record of investigation
Inspector Observation Language: "Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications]. Specifically, observed during inspection of Fresenius Kabi USA, LLC on 2026-05-14."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 211.42(c)(10)(v)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Cleaning System
Inspector Observation Language: "Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, observed during inspection of Fresenius Kabi USA, LLC on 2026-05-14."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.