FDA Inspection
Xttrium Laboratories, Inc.Xttrium Laboratories, Inc. – FDA Inspection, Dec 31, 2008
Record Details
This FDA Inspection record concerns Xttrium Laboratories, Inc., with an inspection on December 31, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Xttrium Laboratories, Inc.
- Inspection Date
- December 31, 2008
- Product Type
- Drugs
View Company Profile
ID · a071d25f-c84d-4c63-a37e-eaca40e016c8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 545476
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Xttrium Laboratories, Inc.
15| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2026 | Not classified | Chicago District Office | |
| June 18, 2025 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 15, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Xttrium Laboratories, Inc.
- FDA Inspection 1324176 - 2026-06-16
- FDA Inspection 1273417 - 2025-06-18
- FDA Inspection 1234354 - 2024-03-08
- FDA Inspection 1230448 - 2024-02-06
- FDA Inspection 1046665 - 2018-03-15
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