Xttrium Laboratories, Inc.
Form 483 issued July 11, 2016 · Mount Prospect, Illinois
- Inspection
- Jun 6 – Jul 11, 2016
- Investigators
- Christopher D. Leach· Marie B. Buen-Bigornia
- Observations
- 6
- Pages
- 4
- FEI number
- 3008436464
In short: On July 11, 2016, FDA issued a Form 483 with 6 observations to Xttrium Laboratories, Inc. in Mount Prospect, Illinois (FEI 3008436464) after an inspection that ran Jun 6 – Jul 11, 2016. The investigators were Christopher D. Leach and Marie B. Buen-Bigornia. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
- 02
Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 04
Representative samples are not taken of each shipment of each lot of components…
This inspection in context
Christopher D. Leach
11 documents · 2013–2018
Cites 211.42 (design and construction features) 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 211.67(b)(5)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xttrium Laboratories, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Xttrium Laboratories, Inc.?
Christopher D. Leach and Marie B. Buen-Bigornia are named on this Form 483, for the inspection of Jun 6 – Jul 11, 2016. Each investigator has a profile showing what they cite most.
When was Xttrium Laboratories, Inc. inspected by FDA?
The inspection ran Jun 6 – Jul 11, 2016, and the Form 483 is dated July 11, 2016.
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.