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FDA Inspection
•MEDLINE INDUSTRIES, LP - Northfield•August 29, 2025

MEDLINE INDUSTRIES, LP - Northfield – FDA Inspection, Aug 29, 2025

Record Details

This FDA Inspection record concerns MEDLINE INDUSTRIES, LP - Northfield, with an inspection on August 29, 2025, issued by the Chicago District Office, covering medical devices & rad health.

Company
MEDLINE INDUSTRIES, LP - Northfield
Inspection Date
August 29, 2025
Product Type
Medical Devices & Rad Health
Office
Chicago District Office
People
  • Edward E. Lockwood (Issuing Officer)
  • Michelle J. Glembin (Company Rep)
View Company Profile

ID · 85f627b0-08eb-4bea-8727-1a82e81ea750

Inspection Facts

Inspection number
1260204
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

5
  1. 21 CFR 803.50(a)(1)Report of Death or Serious Injury
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  4. 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
  5. 21 CFR 820.90(a)Nonconforming product control

Full citation text and observation details available on the Dashboard.

Other FDA inspections of MEDLINE INDUSTRIES, LP - Northfield

7
DateClassificationOfficeProject area
January 22, 2024OAICenter for Devices and Radiological HealthCompliance: Devices
April 6, 2022VAICenter for Devices and Radiological HealthCompliance: Devices
May 26, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
March 20, 2013NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
January 21, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for MEDLINE INDUSTRIES, LP - Northfield
  • FDA Inspection 1227453 - 2024-01-22
  • FDA Inspection 1166522 - 2022-04-06
  • FDA Inspection 984848 - 2016-05-26
  • FDA Inspection 822017 - 2013-03-20
  • FDA Inspection 706656 - 2011-01-21

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