Form FDA 483 · Issued 2026-02-06
Medline Industries - Arlington Heights — FDA Form 483 Analysis
FEI: 1417411 · Sector: Medical Devices (Medical Device Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Medline Industries - Arlington Heights (FEI 1417411) on 2026-02-06 following an inspection of its medical device manufacturer operations in Illinois. The report documents 5 inspection observations centered on Supplier Qualification & Foreign Supplier Verification (FSVP), Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 820.50(a)(1)
Supplier Qualification & Foreign Supplier Verification (FSVP)
FIRST-TIME OBSERVATION
Evaluation and Selection, Suppliers, Contractors, etc.
Inspector Observation Language: "Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements. Specifically, observed during inspection of Medline Industries - Arlington Heights on 2026-02-06."
Plain-English Meaning: Failure to develop or maintain a Foreign Supplier Verification Program (FSVP) or approved vendor qualification file verifying that raw material suppliers meet U.S. FDA safety standards.
Standard CAPA Remediation Path: Maintain an Approved Supplier List (ASL) with hazard analysis, third-party GMP audit certificates, and FSVP importer identification for every foreign ingredient.
Observation #2 · 21 CFR 820.160(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Distribution records
Inspector Observation Language: "Distribution records [were not maintained] [do not include or refer to the location of required information]. Specifically, observed during inspection of Medline Industries - Arlington Heights on 2026-02-06."
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 803.40(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Report of death, injury
Inspector Observation Language: "The importer failed to submit a report to FDA, with a copy to the manufacturer, within 30 days after receiving information that one of its marketed devices may have caused or contributed to a [death] [serious injury]. Specifically, observed during inspection of Medline Industries - Arlington Heights on 2026-02-06."
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 #4 · 21 CFR 812.43(c)(5)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
No financial disclosure info in investigator agreement
Inspector Observation Language: "A signed agreement was not obtained from each participating investigator that includes [sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement] [a commitment to promptly update financial disclosure information if any relevant changes occur during the investigation and for one year following completion of the study]. Specifically, observed during inspection of Medline Industries - Arlington Heights on 2026-02-06."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #5 · 21 CFR 812.140(a)(4)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Investigator record of protocol deviations inadequate
Inspector Observation Language: "Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete] [current]. Specifically,observed during inspection of Medline Industries - Arlington Heights on 2026-02-06."
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.