FDA Inspection
MEDLINE INDUSTRIES, LP - NorthfieldMEDLINE INDUSTRIES, LP - Northfield – FDA Inspection, Jan 22, 2024
Record Details
This FDA Inspection record concerns MEDLINE INDUSTRIES, LP - Northfield, with an inspection on January 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · dc8f08f9-994f-4d08-bedc-107d72955545
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1227453
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MEDLINE INDUSTRIES, LP - Northfield
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2025 | Not classified | Chicago District Office | Compliance: Medical Devices |
| April 6, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 26, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 20, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MEDLINE INDUSTRIES, LP - Northfield
- FDA Inspection 1260204 - 2025-08-29
- FDA Inspection 1166522 - 2022-04-06
- FDA Inspection 984848 - 2016-05-26
- FDA Inspection 822017 - 2013-03-20
- FDA Inspection 706656 - 2011-01-21
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.