Xttrium Laboratories, Inc.
Form 483 issued March 15, 2018 · Mount Prospect, Illinois
- Inspection
- Nov 14, 2017 – Mar 15, 2018
- Investigators
- Nicholas P. Diorio· Norman K. Starks
- Observations
- 1
- Pages
- 2
- FEI number
- 3008436464
In short: On March 15, 2018, FDA issued a Form 483 with 1 observation to Xttrium Laboratories, Inc. in Mount Prospect, Illinois (FEI 3008436464) after an inspection that ran Nov 14, 2017 – Mar 15, 2018. The investigators were Nicholas P. Diorio and Norman K. Starks. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
This inspection in context
Nicholas P. Diorio
8 documents · 2013–2025
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Illinois.
The firmXttrium Laboratories, 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 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xttrium Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Xttrium Laboratories, Inc.?
Nicholas P. Diorio and Norman K. Starks are named on this Form 483, for the inspection of Nov 14, 2017 – Mar 15, 2018. Each investigator has a profile showing what they cite most.
When was Xttrium Laboratories, Inc. inspected by FDA?
The inspection ran Nov 14, 2017 – Mar 15, 2018, and the Form 483 is dated March 15, 2018.
How do I get the full Form 483 for Xttrium Laboratories, 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.