Medline Industries, Inc./Medline
Form 483 issued March 31, 2016 · Mundelein, Illinois
- Inspection
- Mar 21 – Mar 31, 2016
- Investigator
- Debra I. Love
- Observations
- 1
- Pages
- 1
- FEI number
- 3000965328
In short: On March 31, 2016, FDA issued a Form 483 with 1 observation to Medline Industries, Inc./Medline in Mundelein, Illinois (FEI 3000965328) after an inspection that ran Mar 21 – Mar 31, 2016. The investigator was Debra I. Love. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records are deficient in that they do not include all calculations performed during…
This inspection in context
Debra I. Love
13 documents · 2009–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmMedline Industries, Inc./Medline history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medline Industries, Inc./Medline?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Medline Industries, Inc./Medline?
Debra I. Love is named on this Form 483, for the inspection of Mar 21 – Mar 31, 2016. Each investigator has a profile showing what they cite most.
When was Medline Industries, Inc./Medline inspected by FDA?
The inspection ran Mar 21 – Mar 31, 2016, and the Form 483 is dated March 31, 2016.
How do I get the full Form 483 for Medline Industries, Inc./Medline?
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.