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FDA Inspection
•Xttrium Laboratories, Inc.•June 18, 2025

Xttrium Laboratories, Inc. – FDA Inspection, Jun 18, 2025

Record Details

This FDA Inspection record concerns Xttrium Laboratories, Inc., with an inspection on June 18, 2025, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Xttrium Laboratories, Inc.
Inspection Date
June 18, 2025
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Nibin Varghese (Investigator)
  • Ramia Brzenjy (Issuing Officer)
  • Supreet K. Sran (Issuing Officer)
  • Tyler M. Peterson (Issuing Officer)
View Company Profile

ID · ac02e451-de34-435b-bceb-4bf5ef75cc27

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1273417
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

Other FDA inspections of Xttrium Laboratories, Inc.

15
DateClassificationOfficeProject area
June 16, 2026Not classifiedChicago District Office
March 8, 2024VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 6, 2024NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
March 15, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 11, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 15 other inspections on the company page
Other documents for Xttrium Laboratories, Inc.
  • FDA Inspection 1324176 - 2026-06-16
  • FDA Inspection 1234354 - 2024-03-08
  • FDA Inspection 1230448 - 2024-02-06
  • FDA Inspection 1046665 - 2018-03-15
  • FDA Inspection 977965 - 2016-07-11

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