Medline Industries, LP (f/k/a Medline Industries, Inc.)
Form 483 issued May 25, 2018 · Hartland, Wisconsin
- Inspection
- May 22 – May 25, 2018
- Investigator
- Andrew J. Idzior
- Observations
- 3
- Pages
- 3
- FEI number
- 3011508621
In short: On May 25, 2018, FDA issued a Form 483 with 3 observations to Medline Industries, LP (f/k/a Medline Industries, Inc.) in Hartland, Wisconsin (FEI 3011508621) after an inspection that ran May 22 – May 25, 2018. The investigator was Andrew J. Idzior. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Andrew J. Idzior
6 documents · 2013–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmMedline Industries, LP (f/k/a Medline Industries, Inc.) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medline Industries, LP (f/k/a Medline Industries, Inc.)?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Medline Industries, LP (f/k/a Medline Industries, Inc.)?
Andrew J. Idzior is named on this Form 483, for the inspection of May 22 – May 25, 2018. Each investigator has a profile showing what they cite most.
When was Medline Industries, LP (f/k/a Medline Industries, Inc.) inspected by FDA?
The inspection ran May 22 – May 25, 2018, and the Form 483 is dated May 25, 2018.
How do I get the full Form 483 for Medline Industries, LP (f/k/a 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.