Medline Industries, Inc
Form 483 issued January 16, 2025 · Waukegan, Illinois
- Inspection
- Dec 11, 2024 – Jan 16, 2025
- Investigator
- Jean Claude Garay
- Observations
- 6
- Pages
- 11
- FEI number
- 3003983334
In short: On January 16, 2025, FDA issued a Form 483 with 6 observations to Medline Industries, Inc in Waukegan, Illinois (FEI 3003983334) after an inspection that ran Dec 11, 2024 – Jan 16, 2025. The investigator was Jean Claude Garay. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Procedures describing the handling of written and oral complaints related to drug products are…
- 04
An NDA-Field Alert Report was not submitted within three working days of receipt of information conceming…
This inspection in context
Jean Claude Garay
4 documents · 2024–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Illinois.
The firmMedline Industries, Inc history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medline Industries, Inc?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Medline Industries, Inc?
Jean Claude Garay is named on this Form 483, for the inspection of Dec 11, 2024 – Jan 16, 2025. Each investigator has a profile showing what they cite most.
When was Medline Industries, Inc inspected by FDA?
The inspection ran Dec 11, 2024 – Jan 16, 2025, and the Form 483 is dated January 16, 2025.
How do I get the full Form 483 for Medline Industries, Inc?
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.