Medline Industries, Inc
Form 483 issued March 17, 2016 · Waukegan, Illinois
- Inspection
- Feb 26 – Mar 17, 2016
- Investigator
- Debra I. Love
- Observations
- 4
- Pages
- 4
- FEI number
- 3003983334
In short: On March 17, 2016, FDA issued a Form 483 with 4 observations to Medline Industries, Inc in Waukegan, Illinois (FEI 3003983334) after an inspection that ran Feb 26 – Mar 17, 2016. The investigator was Debra I. Love. Most observations concern quality system.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Written procedures are not followed for evaluations done at least annually and including provisions for a…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent malfunctions and contamination…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
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 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 4 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected Medline Industries, Inc?
Debra I. Love is named on this Form 483, for the inspection of Feb 26 – Mar 17, 2016. Each investigator has a profile showing what they cite most.
When was Medline Industries, Inc inspected by FDA?
The inspection ran Feb 26 – Mar 17, 2016, and the Form 483 is dated March 17, 2016.
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.