Medefil Incorporated
Form 483 issued June 17, 2016 · Glendale Heights, Illinois
- Inspection
- Jun 6 – Jun 17, 2016
- Investigator
- Laurimer Kuilan-Torres
- Observations
- 7
- Pages
- 6
- FEI number
- 3001677091
In short: On June 17, 2016, FDA issued a Form 483 with 7 observations to Medefil Incorporated in Glendale Heights, Illinois (FEI 3001677091) after an inspection that ran Jun 6 – Jun 17, 2016. The investigator was Laurimer Kuilan-Torres. Most observations concern production & process controls and materials.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedmes have not been established to control product that does not…
- 02
Procedures for acceptance of incoming product have…
- 03
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 04
Drug product containers were not clean arrd sterilized and processed to remove pyrogenic properties to assme…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmMedefil Incorporated history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medefil Incorporated?
FDA listed 7 observations on this Form 483, mostly about production & process controls, materials and cAPA. The opening words of each observation are shown on this page.
Who inspected Medefil Incorporated?
Laurimer Kuilan-Torres is named on this Form 483, for the inspection of Jun 6 – Jun 17, 2016. Each investigator has a profile showing what they cite most.
When was Medefil Incorporated inspected by FDA?
The inspection ran Jun 6 – Jun 17, 2016, and the Form 483 is dated June 17, 2016.
How do I get the full Form 483 for Medefil Incorporated?
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.