Medline Industries, Inc
FDA inspection history across 3 sites, 2004 to 2026
- 2
- Warning letters
- 2
- Form 483s
Every document, by year
- Warning letter
- Form 483
2004: one warning letter; 2016: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter, at Mundelein, Illinois.
- 2016One Form 483, at Waukegan, Illinois.
- 2025–26One Form 483 and one warning letter, at Waukegan, Illinois and Northfield, Illinois.
- 2025The longest 483 on file: 6 observations over 11 pages at Waukegan, Illinois.
Cited most
Across all Medline Industries observations on file
- 21 CFR 211.198Complaint files3
- 21 CFR 211.192Production record review2
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.180General requirements1
The complete Medline Industries file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Waukegan, Illinois
Two Form 483s · 2016 to 2025 · 10 observations
Latest: Form 483, Jan 16, 2025 →Northfield, Illinois
One warning letter · 2026
Latest: Warning letter, May 28, 2026 →Mundelein, Illinois
One warning letter · 2004
Latest: Warning letter, Jul 30, 2004 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-28 | Warning letter Warning letter | Northfield, Illinois | — | $99 |
| 2025-01-16 | 483 Form 483 | Waukegan, Illinois | 6 | $99 |
| 2016-03-17 | 483 Form 483 | Waukegan, Illinois | 4 | $99 |
| 2004-07-30 | Warning letter Warning letter | Mundelein, Illinois | — | $99 |
Investigators on these documents
FEI number 3003983334 · most recent document May 28, 2026
About Medline Industries, Inc
How many FDA Form 483s has Medline Industries, Inc received?
FDA Intel has 2 Form 483s on file for Medline Industries, Inc; the most recent is dated Jan 16, 2025.
When was Medline Industries, Inc last inspected by FDA?
The most recent FDA inspection document on file for Medline Industries, Inc is a Form 483 dated Jan 16, 2025, for the site in Waukegan, Illinois.
What did FDA cite at Medline Industries, Inc?
The regulations cited most in the observations on file for Medline Industries, Inc are 21 CFR 211.198 (Complaint files), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time.
Has Medline Industries, Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Medline Industries, Inc; the most recent is dated May 28, 2026.