Xttrium Laboratories, Inc.
Form 483 issued March 8, 2024 · Mount Prospect, Illinois
- Inspection
- Feb 27 – Mar 8, 2024
- Investigators
- Gabriel Bermudez-Picart· Nibin Varghese· Tyler Peterson
- Observations
- 7
- Pages
- 7
- FEI number
- 3008436464
In short: On March 8, 2024, FDA issued a Form 483 with 7 observations to Xttrium Laboratories, Inc. in Mount Prospect, Illinois (FEI 3008436464) after an inspection that ran Feb 27 – Mar 8, 2024. The investigators were Gabriel Bermudez-Picart, Nibin Varghese and Tyler Peterson. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Gabriel Bermudez-Picart
3 documents · 2024–2026
Cites 211.100 (written procedures; deviations) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xttrium Laboratories, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Xttrium Laboratories, Inc.?
Gabriel Bermudez-Picart, Nibin Varghese and Tyler Peterson are named on this Form 483, for the inspection of Feb 27 – Mar 8, 2024. Each investigator has a profile showing what they cite most.
When was Xttrium Laboratories, Inc. inspected by FDA?
The inspection ran Feb 27 – Mar 8, 2024, and the Form 483 is dated March 8, 2024.
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.