Xttrium Laboratories, Inc.
FDA inspection history across 2 sites, 2009 to 2024
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter; 2016: one Form 483; 2018: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter, at Chicago, Illinois.
- 2016–18Two Form 483s, at Mount Prospect, Illinois.
- 2024One Form 483, at Mount Prospect, Illinois.
- 2024The longest 483 on file: 7 observations over 7 pages at Mount Prospect, Illinois.
Cited most
Across all Xttrium Laboratories observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
The complete Xttrium Laboratories file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Mount Prospect, Illinois
Three Form 483s · 2016 to 2024 · 14 observations
Latest: Form 483, Mar 8, 2024 →Chicago, Illinois
One warning letter · 2009
Latest: Warning letter, May 20, 2009 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-08 | 483 Form 483 | Mount Prospect, Illinois | 7 | $99 |
| 2018-03-15 | 483 Form 483 | Mount Prospect, Illinois | 1 | $99 |
| 2016-07-11 | 483 Form 483 | Mount Prospect, Illinois | 6 | $99 |
| 2009-05-20 | Warning letter Warning letter | Chicago, Illinois | — | $99 |
Investigators on these documents
Christopher D. Leach (1)Gabriel Bermudez-Picart (1)Marie B. Buen-Bigornia (1)Nibin Varghese (1)Nicholas P. Diorio (1)Norman K. Starks (1)Tyler Peterson (1)
FEI number 3008436464 · most recent document Mar 8, 2024
About Xttrium Laboratories, Inc.
How many FDA Form 483s has Xttrium Laboratories, Inc. received?
FDA Intel has 3 Form 483s on file for Xttrium Laboratories, Inc.; the most recent is dated Mar 8, 2024.
When was Xttrium Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Xttrium Laboratories, Inc. is a Form 483 dated Mar 8, 2024, for the site in Mount Prospect, Illinois.
What did FDA cite at Xttrium Laboratories, Inc.?
The regulations cited most in the observations on file for Xttrium Laboratories, Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time.
Has Xttrium Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Xttrium Laboratories, Inc.; the most recent is dated May 20, 2009.