Sage Products LLC
Form 483 issued September 1, 2016 · Cary, Illinois
- Inspection
- Jun 2 – Sep 1, 2016
- Investigators
- Brittani N. Franklin· Christopher D. Leach· Debra I. Love
- Observations
- 6
- Pages
- 7
- FEI number
- 1419181
In short: On September 1, 2016, FDA issued a Form 483 with 6 observations to Sage Products LLC in Cary, Illinois (FEI 1419181) after an inspection that ran Jun 2 – Sep 1, 2016. The investigators were Brittani N. Franklin, Christopher D. Leach, Debra I. Love, Michael E. Maselli, Nicholas P. Diorio and That Q. Dang. Most observations concern materials and laboratory controls.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 02
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Brittani N. Franklin
5 documents · 2016–2019
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Illinois.
The firmSage Products LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sage Products LLC?
FDA listed 6 observations on this Form 483, mostly about materials, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sage Products LLC?
Brittani N. Franklin, Christopher D. Leach, Debra I. Love, Michael E. Maselli, Nicholas P. Diorio and That Q. Dang are named on this Form 483, for the inspection of Jun 2 – Sep 1, 2016. Each investigator has a profile showing what they cite most.
When was Sage Products LLC inspected by FDA?
The inspection ran Jun 2 – Sep 1, 2016, and the Form 483 is dated September 1, 2016.
How do I get the full Form 483 for Sage Products LLC?
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.