Form FDA 483 · Issued 2026-02-18
Fresenius Kabi USA LLC — FDA Form 483 Analysis
FEI: 1450022 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Sterile Drug Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Fresenius Kabi USA LLC (FEI 1450022) on 2026-02-18 following an inspection of its sterile drug manufacturer operations in Illinois. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 3 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.110(c)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
In-process materials characteristics testing
Inspector Observation Language: "In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the quality control unit [during the production process] [after storage for long periods]. Specifically, observed during inspection of Fresenius Kabi USA LLC on 2026-02-18."
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 211.176
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Failing to test for penicillin cross-contamination
Inspector Observation Language: "Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin. Specifically, observed during inspection of Fresenius Kabi USA LLC on 2026-02-18."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #3 · 21 CFR 211.194(a)(5)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Calculations performed are in the records
Inspector Observation Language: "Laboratory records do not include a record of all calculations performed in connection with the test. Specifically, observed during inspection of Fresenius Kabi USA LLC on 2026-02-18."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.