Sage Products LLC
Form 483 issued June 7, 2019 · Cary, Illinois
- Inspection
- Jun 3 – Jun 7, 2019
- Investigators
- Emilie Kahn· Vioela J. Caze
- Observations
- 2
- Pages
- 4
- FEI number
- 1419181
In short: On June 7, 2019, FDA issued a Form 483 with 2 observations to Sage Products LLC in Cary, Illinois (FEI 1419181) after an inspection that ran Jun 3 – Jun 7, 2019. The investigators were Emilie Kahn and Vioela J. Caze. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of…
- 02
Deviations from written test procedures and laboratory mechanisms are…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sage Products LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sage Products LLC?
Emilie Kahn and Vioela J. Caze are named on this Form 483, for the inspection of Jun 3 – Jun 7, 2019. Each investigator has a profile showing what they cite most.
When was Sage Products LLC inspected by FDA?
The inspection ran Jun 3 – Jun 7, 2019, and the Form 483 is dated June 7, 2019.
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.