MEDLINE INDUSTRIES, LP - Northfield
Form 483 issued January 22, 2024 · Northfield, Illinois
- Inspection
- Dec 11, 2023 – Jan 22, 2024
- Investigators
- Michelle J. Glembin· Natasha R. Johnson
- Observations
- 5
- Pages
- 12
- FEI number
- 1417592
In short: On January 22, 2024, FDA issued a Form 483 with 5 observations to MEDLINE INDUSTRIES, LP - Northfield in Northfield, Illinois (FEI 1417592) after an inspection that ran Dec 11, 2023 – Jan 22, 2024. The investigators were Michelle J. Glembin and Natasha R. Johnson. Most observations concern cAPA and design controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Ail MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procediues for design change have…
- 04
Procedures for collective and preventive action have…
This inspection in context
Michelle J. Glembin
5 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Wisconsin.
The firmMEDLINE INDUSTRIES, LP - Northfield history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MEDLINE INDUSTRIES, LP - Northfield?
FDA listed 5 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected MEDLINE INDUSTRIES, LP - Northfield?
Michelle J. Glembin and Natasha R. Johnson are named on this Form 483, for the inspection of Dec 11, 2023 – Jan 22, 2024. Each investigator has a profile showing what they cite most.
When was MEDLINE INDUSTRIES, LP - Northfield inspected by FDA?
The inspection ran Dec 11, 2023 – Jan 22, 2024, and the Form 483 is dated January 22, 2024.
How do I get the full Form 483 for MEDLINE INDUSTRIES, LP - Northfield?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.